U.S. patent number 10,517,768 [Application Number 15/293,084] was granted by the patent office on 2019-12-31 for skin treatment devices with locking mechanisms.
This patent grant is currently assigned to Neodyne Biosciences, Inc.. The grantee listed for this patent is Neodyne Biosciences, Inc.. Invention is credited to William R. Beasley, Darren G. Doud, Brett A. Follmer, Jasper Jackson, John A. Zepeda.
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United States Patent |
10,517,768 |
Zepeda , et al. |
December 31, 2019 |
Skin treatment devices with locking mechanisms
Abstract
Devices, kits and methods described herein may be for wound
healing, including the treatment, amelioration, or prevention of
scars and/or keloids by applying and/or maintaining a
pre-determined strain in an elastic skin treatment device that is
then affixed to the skin surface using skin adhesives to transfer a
generally planar force from the bandage to the skin surface.
Applicators are used to apply and/or maintain the strains, and some
of the applicators are further configured to provide at least some
mechanical advantage to the user when exerting loads onto the skin
treatment device.
Inventors: |
Zepeda; John A. (Los Altos,
CA), Jackson; Jasper (Newark, CA), Beasley; William
R. (Los Altos, CA), Doud; Darren G. (Los Altos, CA),
Follmer; Brett A. (Santa Clara, CA) |
Applicant: |
Name |
City |
State |
Country |
Type |
Neodyne Biosciences, Inc. |
Menlo Park |
CA |
US |
|
|
Assignee: |
Neodyne Biosciences, Inc.
(Menlo Park, CA)
|
Family
ID: |
43586823 |
Appl.
No.: |
15/293,084 |
Filed: |
October 13, 2016 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20170189240 A1 |
Jul 6, 2017 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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14158741 |
Jan 17, 2014 |
9492329 |
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13089129 |
Mar 18, 2014 |
8674164 |
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12854859 |
Nov 26, 2013 |
8592640 |
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61264205 |
Nov 24, 2009 |
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61243020 |
Sep 16, 2009 |
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61233122 |
Aug 11, 2009 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F
15/001 (20130101); A61F 15/005 (20130101); A61F
13/00085 (20130101); A61F 13/0253 (20130101); A61F
13/0236 (20130101); A61F 13/0256 (20130101); A61L
15/26 (20130101); A61F 13/023 (20130101); A61B
17/085 (20130101); A61F 13/0243 (20130101); A61F
13/00076 (20130101); A61B 90/02 (20160201); A61F
13/0266 (20130101); A61F 13/00038 (20130101); A61L
15/26 (20130101); C08L 83/04 (20130101); A61F
13/0246 (20130101); A61B 17/08 (20130101); A61F
13/0259 (20130101) |
Current International
Class: |
A61F
13/00 (20060101); A61L 15/26 (20060101); A61F
15/00 (20060101); A61F 13/02 (20060101); A61B
90/00 (20160101); A61B 17/08 (20060101) |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
2321491 |
|
Sep 1999 |
|
CA |
|
2321491 |
|
Sep 1999 |
|
CA |
|
2621387 |
|
Mar 2007 |
|
CA |
|
2621387 |
|
Mar 2007 |
|
CA |
|
1414842 |
|
Apr 2003 |
|
CN |
|
1414842 |
|
Apr 2003 |
|
CN |
|
1608604 |
|
Apr 2005 |
|
CN |
|
1608604 |
|
Apr 2005 |
|
CN |
|
102665623 |
|
Sep 2012 |
|
CN |
|
102665623 |
|
Sep 2012 |
|
CN |
|
2161011 |
|
Mar 2010 |
|
EP |
|
2161011 |
|
Mar 2010 |
|
EP |
|
2 464 322 |
|
Jun 2012 |
|
EP |
|
2464322 |
|
Jun 2012 |
|
EP |
|
2004-515256 |
|
May 2004 |
|
JP |
|
2004515256 |
|
May 2004 |
|
JP |
|
2004-223087 |
|
Aug 2004 |
|
JP |
|
2004223087 |
|
Aug 2004 |
|
JP |
|
2004-536898 |
|
Dec 2004 |
|
JP |
|
2004536898 |
|
Dec 2004 |
|
JP |
|
2006-513748 |
|
Apr 2006 |
|
JP |
|
2006513748 |
|
Apr 2006 |
|
JP |
|
2007-537781 |
|
Dec 2007 |
|
JP |
|
2007537781 |
|
Dec 2007 |
|
JP |
|
2009-545382 |
|
Dec 2009 |
|
JP |
|
2009545382 |
|
Dec 2009 |
|
JP |
|
2013-501591 |
|
Jan 2013 |
|
JP |
|
2013501591 |
|
Jan 2013 |
|
JP |
|
2 019 138 |
|
Sep 1994 |
|
RU |
|
2019138 |
|
Sep 1994 |
|
RU |
|
9717919 |
|
May 1997 |
|
WO |
|
WO 97/17919 |
|
May 1997 |
|
WO |
|
9730700 |
|
Aug 1997 |
|
WO |
|
WO97/30700 |
|
Aug 1997 |
|
WO |
|
WO97/30700 |
|
Aug 1997 |
|
WO |
|
9730700 |
|
Oct 1997 |
|
WO |
|
0053139 |
|
Sep 2000 |
|
WO |
|
WO00/53139 |
|
Sep 2000 |
|
WO |
|
0139693 |
|
Jun 2001 |
|
WO |
|
WO01/39693 |
|
Jun 2001 |
|
WO |
|
WO01/39693 |
|
Jun 2001 |
|
WO |
|
0139693 |
|
Dec 2001 |
|
WO |
|
0215816 |
|
Feb 2002 |
|
WO |
|
WO02/15816 |
|
Feb 2002 |
|
WO |
|
WO02/15816 |
|
Feb 2002 |
|
WO |
|
0245698 |
|
Jun 2002 |
|
WO |
|
WO02/45698 |
|
Jun 2002 |
|
WO |
|
WO02/45698 |
|
Jun 2002 |
|
WO |
|
0245698 |
|
Jul 2002 |
|
WO |
|
02092783 |
|
Nov 2002 |
|
WO |
|
2002087645 |
|
Nov 2002 |
|
WO |
|
WO 02/092783 |
|
Nov 2002 |
|
WO |
|
WO 02/092783 |
|
Nov 2002 |
|
WO |
|
WO2002/087645 |
|
Nov 2002 |
|
WO |
|
0215816 |
|
Oct 2003 |
|
WO |
|
2004060413 |
|
Jul 2004 |
|
WO |
|
WO2004/060413 |
|
Jul 2004 |
|
WO |
|
02092783 |
|
Jul 2005 |
|
WO |
|
2005079674 |
|
Sep 2005 |
|
WO |
|
WO2005/079674 |
|
Sep 2005 |
|
WO |
|
2005096981 |
|
Oct 2005 |
|
WO |
|
WO2005/096981 |
|
Oct 2005 |
|
WO |
|
WO2005/096981 |
|
Oct 2005 |
|
WO |
|
2005096981 |
|
Mar 2006 |
|
WO |
|
2006124671 |
|
Nov 2006 |
|
WO |
|
2006124671 |
|
Apr 2007 |
|
WO |
|
2008019051 |
|
Feb 2008 |
|
WO |
|
WO2008/019051 |
|
Feb 2008 |
|
WO |
|
WO2008/019051 |
|
Feb 2008 |
|
WO |
|
2008019051 |
|
Apr 2008 |
|
WO |
|
2011019859 |
|
Feb 2011 |
|
WO |
|
WO2011/019859 |
|
Feb 2011 |
|
WO |
|
WO2011/019859 |
|
Feb 2011 |
|
WO |
|
2011019859 |
|
Apr 2011 |
|
WO |
|
2012094648 |
|
Jul 2012 |
|
WO |
|
WO2012/094648 |
|
Jul 2012 |
|
WO |
|
2012119131 |
|
Sep 2012 |
|
WO |
|
WO2012/119131 |
|
Sep 2012 |
|
WO |
|
Other References
3M Healthcare. (2006). "3M.TM. Steri-Strip.TM. S Surgical Skin
Closure. The Simple, Non-Invase Alternative to Staples and Sutures
from the Steri-Strip Family," HealthCare: St. Paul, MN, two pages.
cited by applicant .
3M Healthcare. (Oct. 19, 2006). "3M.TM. Steri-Strip-Strip.TM. S
Surgical Skin Closure: Commonly Asked Questions," 3M HealthCare:
St. Paul, MN, pp. 1-8. cited by applicant .
3M Healthcare. (2007). "3M.TM. Steri-Strip.TM. S Surgical Skin
Closure. Application Instructions," 3M HealthCare: St. Paul, MN,
two pages. cited by applicant .
3M Medical. (2006). "They Say Every Scar Tells a Story," 3M
HealthCare: St. Paul, MN, one page. cited by applicant .
3M Medical. (2006). "3M.TM. Steri-Strip.TM. S Surgical Skin
Closure. Patient Care Information," 3M HealthCare: St. Paul, MN,
two pages. cited by applicant .
3M Medical. (2007). "3M.TM. Steri-Strip.TM. S Surgical Skin
Closure. Application Examples, Comparisons and Results," 3M
HealthCare: St. Paul, MN, four pages. cited by applicant .
Aarabi, S. et al. (Oct. 2007). "Mechanical Load Initiates
Hypertrophic Scar Formation Through Decreased Cellular Apoptosis,"
The FASEB Journal 21(12):3250-3261. cited by applicant .
Advisory Action dated Feb. 4, 2014, for U.S. Appl. No. 13/029,023,
filed Feb. 16, 2011, 4 pages. cited by applicant .
Advisory Action for U.S. Appl. No. 13/789,264, dated Oct. 19, 2015,
3 pages. cited by applicant .
Advisory Action for U.S. Appl. No. 13/789,237, dated Oct. 8, 2015,
5 pages. cited by applicant .
Al-Attar, A. et al. (Jan. 2006). "Keloid Pathogenesis and
Treatment," Plastic and Reconstructive Surgery 117(1): 286-300.
cited by applicant .
Angelini, G.D. et al. (1984). "Comparative Study of Leg Wound Skin
Closure in Coronary Artery Bypass Graft Operations," Thorax
39:942-945. cited by applicant .
Anonymous (2003). "3M.TM. Steri-Strip.TM. Adhesive Skin Closures,"
3M HealthCare Brochure, twelve pages. cited by applicant .
Anonymous. (2005). "3M.TM. Tegaderm.TM. Family of Transparent
Dressings," 3M HealthCare Brochure, six pages. cited by applicant
.
Atkinson, J-A.M. et al. (Nov. 2005). "A Randomized, Controlled
Trial to Determine the Efficacy of Paper Tape in Preventing
Hypertrophic Scar Formation in Surgical Incisions that Traverse
Langer's Skin Tension Lines," Plastic and Reconstructive Surgery
116(6):1648-1656. cited by applicant .
Bachert, B. et al. (2003). "Probing Elastic Modulus and Depth of a
Two Layer Human Skin Model with Piezoelectric Cantilevers,"
Biomedical Engineering Senior Design Team, Drexel University, 27
pages. cited by applicant .
Berman, B. et al. (Mar. 3, 2005). "Keloid and Hypertrophic Scar,"
located at <http://www.emedicine.com/DERM/topic205.htm>, last
visited on Nov. 19, 2007, 23 pages. cited by applicant .
Bunker, T.D. (1983). "Problems with the Use of Op-Site Sutureless
Skin Closures in Orthopaedic Procedures," Annals of the Royal
College of Surgeons of England 65:260-262. cited by applicant .
Burd, A. et al. (Dec. 2005). "Hypertrophic Response and Keloid
Diathesis: Two Very Different Forms of Scar," Plastic and
Reconstructive Surgery 116(7):150-157. cited by applicant .
Final Office Action for U.S. Appl. No. 13/411,443 dated Jun. 3,
2015, 13 pages. cited by applicant .
Final Office Action for U.S. Appl. No. 13/789,237, dated Aug. 27,
2015, 9 pages. cited by applicant .
Final Office Action for U.S. Appl. No. 13/789,264, dated Jul. 16,
2015, 11 pages. cited by applicant .
Final Office Action for U.S. Appl. No. 13/029,023, dated Nov. 25,
2013, 12 pages. cited by applicant .
Final Office Action for U.S. Appl. No. 13/411,394, dated Mar. 18,
2014, 12 pages. cited by applicant .
Final Office Action for U.S. Appl. No. 13/789,229, dated Jan. 15,
2015, 21 pages. cited by applicant .
Final Office Action for U.S. Appl. No. 13/411,394, dated Feb. 1,
2016, 14 pages. cited by applicant .
Final Office Action dated May 23, 2013, for U.S. Appl. No.
13/089,105, filed Apr. 18, 2011, 14 pages. cited by applicant .
Final Office Action dated Oct. 20, 2016, for U.S. Appl. No.
13/411,443, filed Mar. 2, 2012, 15 pages. cited by applicant .
International Search Report and Written Opinion for PCT Patent
Application No. PCT/US2013/025449, dated Feb. 5, 2015, 8 pages.
cited by applicant .
International Search Report and Written Opionion dated Feb. 8,
2011, for PCT Patent Application No. PCT/US2010/045239, filed on
Aug. 11, 2010, one page. cited by applicant .
International Search Report dated May 29, 2012, for PCT Patent
Application No. PCT/US2012/25510, filed Feb. 16, 2012, four pages.
cited by applicant .
Mustoe, T.A. et al. (Nov. 2005). "A Randomized, Controlled Trial to
Determine the Efficacy of Paper Tape in Preventing Hypertrophic
Scar Formation in Surgical Incisions that Traverse Langer's Skin
Tension Lines," Plastic and Reconstructive Surgery (Discussion)
116(6):1657-1658. cited by applicant .
Non-Final Office Action dated Apr. 13, 2009, for U.S. Appl. No.
11/888,978, filed Aug. 3, 2007, 20 pages. cited by applicant .
Non-Final Office Action dated Mar. 7, 2011, for U.S. Appl. No.
12/358,159, filed Jan. 22, 2009, 14 pages. cited by applicant .
Non-Final Office Action dated Aug. 5, 2011, for U.S. Appl. No.
12/358,162, filed Jan. 22, 2009, 13 pages. cited by applicant .
Non-Final Office Action dated Aug. 5, 2011, for U.S. Appl. No.
12/358,164, filed Jan. 22, 2009, 15 pages. cited by applicant .
Non-Final Office Action dated Aug. 8, 2012, for U.S. Appl. No.
13/089,104, filed Apr. 18 2011, 13 pages. cited by applicant .
Non-Final Office Action dated May 9, 2012, for U.S. Appl. No.
13/315,214, filed Dec. 8, 2011, 6 pages. cited by applicant .
Non-Final Office Action dated Jul. 20, 2012, for U.S. Appl. No.
13/089,105, filed Apr. 18, 2011, 17 pages. cited by applicant .
Non-Final Office Action dated Aug. 21, 2012, for U.S. Appl. No.
13/315,214, filed Dec. 8, 2011, 5 pages. cited by applicant .
Non-Final Office Action dated Mar. 15, 2013, for U.S. Appl. No.
13/029,023, filed Feb. 16, 2011, 8 pages. cited by applicant .
Non-Final Office Action for U.S. Appl. No. 13/411,443, dated Jan.
13, 2016, 14 pages. cited by applicant .
Non Final Office Action for U.S. Appl. No. 13/089,129, dated Jun.
28, 2013, 11 pages. cited by applicant .
Non Final Office Action for U.S. Appl. No. 13/029,023, dated Jun.
10, 2015, 12 pages. cited by applicant .
Non-Final Office Action for U.S. Appl. No. 13/029,023, dated Aug.
14, 2014, 12 pages. cited by applicant .
Non Final Office Action for U.S. Appl. No. 13/089,105, dated Dec.
5, 2013, 14 pages. cited by applicant .
Non-Final Office Action for U.S. Appl. No. 13/089,105 dated Jul.
10, 2014, 8 pages. cited by applicant .
Non-Final Office Action for U.S. Appl. No. 13/089,105, dated Apr.
10, 2015, 15 pages. cited by applicant .
Non-Final Office Action for U.S. Appl. No. 13/345,524, dated Apr.
10, 2015, 12 pages. cited by applicant .
Non-Final Office Action for U.S. Appl. No. 13/345,524, dated Mar.
28, 2014, 12 pages. cited by applicant .
Non-Final Office Action for U.S. Appl. No. 13/411,394, dated Apr.
10, 2015, 15 pages. cited by applicant .
Non-Final Office Action for U.S. Appl. No. 13/411,443, dated Jan.
16, 2015, 12 pages. cited by applicant .
Non Final Office Action for U.S. Appl. No. 13/789,204, dated Oct.
8, 2014, 8 pages. cited by applicant .
Non-Final Office Action for U.S. Appl. No. 13/789,229, dated Jun.
4, 2014, 6 pages. cited by applicant .
Non Final Office Action for U.S. Appl. No. 13/789,237, dated Mar.
31, 2014, 5 pages. cited by applicant .
Non-Final Office Action for U.S. Appl. No. 13/789,264, dated Mar.
26, 2014, 10 pages. cited by applicant .
Non-Final Office Action for U.S. Appl. No. 13/789,512, dated Jan.
25, 2016, 9 pages. cited by applicant .
Non-Final Office Action for U.S. Appl. No. 14/158,741, dated Dec.
16, 2015, 9 pages. cited by applicant .
Non-Final Office Action dated Mar. 29, 2013, for U.S. Appl. No.
12/854,859, Aug. 11, 2010, 11 pages. cited by applicant .
Non-Final Office Action dated Dec. 1, 2016, for U.S. Appl. No.
15/002,253, filed Jan. 20, 2016, 10 pages. cited by applicant .
Non-Final Office Action dated Feb. 2, 2017, for U.S. Appl. No.
15/002,253, filed Jan. 20, 2016, 11 pages. cited by applicant .
Northern Health and Social Services Board. (2005). NHSSB Wound
Management Manual, pp. 1-97. cited by applicant .
Notice of Allowance dated Jan. 19, 2010, for U.S. Appl. No.
11/888,978, filed Aug. 3, 2007, eight pages. cited by applicant
.
Notice of Allowance dated Oct. 11, 2011, for U.S. Appl. No.
12/358,159, filed Jan. 22, 2009, five pages. cited by applicant
.
Notice of Allowance dated Dec. 29, 2011, for U.S. Appl. No.
12/358,162, filed Jan. 22, 2009, eight pages. cited by applicant
.
Notice of Allowance dated Dec. 29, 2011, for U.S. Appl. No.
12/358,164, filed Jan. 22, 2009, seven pages. cited by applicant
.
Notice of Allowance dated Feb. 17, 2012, for U.S. Appl. No.
12/358,164, filed Jan. 22, 2009, eight pages. cited by applicant
.
Notice of Allowance dated Mar. 2, 2012, for U.S. Appl. No.
12/358,162, filed Jan. 22, 2009, eight pages. cited by applicant
.
Notice of Allowance dated Dec. 10, 2012, for U.S. Appl. No.
13/315,214, filed Dec. 8, 2011, eight pages. cited by applicant
.
Notice of Allowance dated Jan. 23, 2013, for U.S. Appl. No.
13/315,214, filed Dec. 8, 2011, two pages. cited by applicant .
Notice of Allowance dated Jan. 8, 2013, for U.S. Appl. No.
13/089,104, filed Apr. 18, 2011, nine pages. cited by applicant
.
Notice of Allowance dated Oct. 9, 2013, for U.S. Appl. No.
12/854,859, filed Aug. 11, 2010, 7 pages. cited by applicant .
Notice of Allowance dated Feb. 12, 2016, for U.S. Appl. No.
13/029,023, filed Feb. 16, 2011, 9 pages. cited by applicant .
Notice of Allowance for U.S. Appl. No. 13/089,129, dated Oct. 28,
2013, 7 pages. cited by applicant .
Notice of Allowance for U.S. Appl. No. 13/089,105, dated Nov. 20,
2015, 5 pages. cited by applicant .
Notice of Allowance dated Jul. 6, 2016, for U.S. Appl. No.
14/158,741, filed Jan. 17, 2014, 8 pages. cited by applicant .
Notice of Allowance for U.S. Appl. No. 13/789,237, dated Nov. 24,
2015, 5 pages. cited by applicant .
Notice of Allowance dated Jan. 11, 2017, for U.S. Appl. No.
14/158,688, filed Jan. 17, 2014, 11 pages. cited by applicant .
Notice of Allowance for U.S. Appl. No. 13/345,524, dated Oct. 5,
2015, 9 pages. cited by applicant .
Shirado, H. et al. (Mar. 2006). "Realization of Human Skin-Like
Texture by Emulating Surface Shape Pattern and Elastic Structure,"
presented at Symposium on Haptic Interfaces for Virtual Environment
and Teleoperator Systems 2006, Mar. 25-26, 2006, Alexandria, VA,
pp. 295-296. cited by applicant .
Wound Care Technologies. (2008). "DERMAClose.TM. RC: Continuous
External Tissue Expander, Brochure No. PL-0020-F," located at <
http://www.woundcaretech.com/sell-sheet.pdf>, last visited on
Sep. 10, 2009, two pages. cited by applicant .
Wound Care Technologies. (2008). "Instructions for Use.
DERMAClose.TM. RC, Brochure No. DR-0079-A," located at <
http://www.dermaclose.com/instructions.pdf>, last visited on
Sep. 10, 2009, two pages. cited by applicant .
U.S. Appl. No. 15/224,393, filed Jul. 29, 2016, by Jackson et al.
(Copy not attached). cited by applicant .
Non-Final Office Action for U.S. Appl. No. 13/789,264, dated Jul.
28, 2016, 10 pages. cited by applicant .
3m Healthcare (May 2004). "Tips for Trouble-Free Taping," 3M
HealthCare: St. Paul, MN, four pages. cited by applicant .
3M Healthcare. (2001). "Reducing the Risk of Superficial Skin
Damage Related to Adhesive Use," 3M HealthCare: St Paul, MN, two
pages. cited by applicant .
3M Healthcare. (2003). "Steri-Strip: Skin Closures," Product
Insert, 3M HealthCare: St. Paul, MN, one page. cited by applicant
.
3M Healthcare. (2006). "3MTM Steri-StripTM S Surgical Skin Closure.
The Simple, Non-Invase Alternative to Staples and Sutures from the
Steri-Strip Family," HealthCare: St. Paul, MN, two pages. cited by
applicant .
3M Healthcare. (Date Unknown). "3M.TM. Steri-Strip.TM. S Surgical
Skin Closure," 3M HealthCare: St. Paul, MN, one page. cited by
applicant .
3M Healthcare. (Date unknown). 3M.TM. Steri-Strip.TM. S Surgical
Skin Closure. Poster of Available Sizes, 3M HealthCare: St Paul,
MN, three pages. cited by applicant .
3M Healthcare. (Jun. 27, 2002). "3M.TM. Steri-Strip.TM. Adhesive
Skin Closures (reinforced): Commonly Asked Questions," 3M
HealthCare: St Paul, MN, pp. 1-4. cited by applicant .
3M Healthcare. (Oct. 19, 2006). "3M.TM. Steri-Strip.TM. S Surgical
Skin Closure: Commonly Asked Questions," 3M Healthcare: St. Paul,
MN, pp. 1-8 cited by applicant .
3M Medical. (2006). "3MTM Steri-StripTM S Surgical Skin Closure,
Patient Care Information," 3M HealthCare: St. Paul, MN, two pages.
cited by applicant .
3M Medical. (2007). "3MTM Steri-StripTM S Surgical Skin Closure.
Application Examples, Comparisons and Results," 3M HealthCare: St,
Paul, MN, four pages. cited by applicant .
Anonymous (2003). "3MTM Steri-StripTM Adhesive Skin Closures," 3M
HealthCare Brochure, twelve pages. cited by applicant .
Anonymous. (2005). "3MTM TegadermTM Family of Transparent
Dressings," 3M HealthCare Brochure, six pages. cited by applicant
.
Anonymous. (2006). "Avocet Polymer Technologies," located at
<http://www.avocetcorp.com/index.html>, last visited on Nov.
5, 2007, one page. cited by applicant .
Anonymous. (2006). "Avogel Scar Hydrogel," located at
<http://www.avocetcorp.com/avogel_scar_hydrogel.html>, last
visited on Nov. 5, 2007, two pages. cited by applicant .
Anonymous. (2006). "Avosil Ointment," located at
<http://www.avocetcorp.com/avosil.html>, last visited on Nov.
5, 2007, three pages. cited by applicant .
Anonymous. (Date Unknown). "Mepiform Instructions of Use," Tendra
Corporation Brochure, two pages. cited by applicant .
Anonymous. (Date Unknown). "Silicone Scar Bandage: Standard Wound
Healing Application," located at
<http://www.thejamushop.com/silicon_sheet_for_keloids.htm>,
last visited on Mar. 18, 2009, four pages. cited by applicant .
Brace, "Definition of Brace", Merriam Webster, Available Online at
<www.merriam-webster.com>, 2015, 4 pages. cited by applicant
.
Canica Design Inc. (Date Unknown). "ABRA.RTM. Abdominal Wall
Closure Set," located at <
http://www.canica.com/instructions/1D1544RA%20-%20ABRA%20CWK08%20IFU.pdf&-
gt;, last visited on Sep. 10, 2009, pp. 1-11. cited by applicant
.
Canica Design Inc. (Date Unknown). "ABRA.RTM. Surgical Skin Closure
Set," located at
<http://www.canica.com/instructions/1D0830RH.pdf>, last
visited on Sep. 10, 2009, pp. 1-4. cited by applicant .
Corrected Notice of Allowability dated Jan. 23, 2013, for U.S.
Appl. No. 13/315,214, filed Dec. 8, 2011, 2 pages. cited by
applicant .
Decision for Grant for Korean Patent Application No.
10-2009-7003220, dated May 14, 2014, 3 pages. cited by applicant
.
Decision for Grant for Korean Patent Application No.
10-2014-7005383, dated Dec. 10, 2014, 3 pages. cited by applicant
.
Extended European Search Report (includes Supplementary European
Search Report and Search Opinion) for European Patent Application
No. 12752239.9, dated Oct. 1, 2014, 7 pages. cited by applicant
.
Extended European Search Report dated Aug. 19, 2013 for European
Patent Application No. 10 808 724.8, filed on Aug. 11, 2010, 8
pages. cited by applicant .
Extended European Search Report dated Feb. 23, 2016, for European
Patent Application No. 13 825 488.3, filed on Feb. 8, 2013, 6
pages. cited by applicant .
Extended European Search Report dated Jun. 19, 2017 for European
Patent Application No. 16205575.0, filed Aug. 11, 2010, 8 pages.
cited by applicant .
Extended European Search Report for European Patent Application No.
12732236.0, dated Jun. 29, 2015, 6 pages. cited by applicant .
International Preliminary Report on Patentability for PCT Patent
Application No. PCT/US2007/017320, dated Feb. 3, 2009, 8 pages.
cited by applicant .
International Preliminary Report on Patentability for PCT Patent
Application No. PCT/US2010/045239, dated Feb. 23, 2012, 10 pages.
cited by applicant .
International Preliminary Report on Patentability for PCT Patent
Application No. PCT/US2012/025510, dated Aug. 29, 2013, 10 pages.
cited by applicant .
International Preliminary Report on Patentability for PCT Patent
Application No. PCT/US2012/027618, dated Sep. 12, 2013, 12 pages.
cited by applicant .
International Preliminary Report on Patentability for PCT Patent
Application No. PCT/US2013/025449, dated Feb. 5, 2015, 7 pages.
cited by applicant .
International Search Report and Written Opinion dated May 1, 2012,
for PCT Patent Application No. PCT/US2012/020561, filed Jan. 6,
2012, three pages. cited by applicant .
International Search Report and Written Opinion dated Feb. 7, 2008,
for PCT Application No. PCT/US2007/017320, filed on Aug. 3, 2007,
11 pages. cited by applicant .
International Search Report and Written Opinion dated Feb. 8, 2011,
for PCT Patent Application No. PCT/US2010/045239, filed on Aug. 11,
2010, one page. cited by applicant .
International Search Report and Written Opinion for PCT Patent
Application No. Pot/US2013/025449, dated Feb. 5, 2015, 8 pages.
cited by applicant .
International Search Report dated Jun. 28, 2012, for PCT Patent
Application No. PCT/US2012/027618, filed Mar. 2, 2012, two pages.
cited by applicant .
International Search Report dated May 29, 2012, for PCT Patent
Application No. PCT/US2012/25510, filed Feb. 16, 2012, three pages.
cited by applicant .
MASK, "Definition of Mask", Merriam Webster, Available Online at
<www.merriam-webster.com>, 2015, 4 pages. cited by applicant
.
Nahabedian, M.Y. (Dec. 2005). "Scar Wars: Optimizing Outcomes with
Reduction Mammaplasty," Plastic and Reconstructive Surgery,
116(7):2026-2029. cited by applicant .
NHSSB Wound Management Manual, Northern Health and Social Services
Board, 2005, pp. 1-97. cited by applicant .
Notice of Allowance for Japanese Patent Application No.
2009-522879, dated Mar. 17, 2014, 6 pages. cited by applicant .
Notice of Allowance for Japanese Patent Application No.
2012-524855, dated Apr. 30, 2015, 3 pages. cited by applicant .
Notice of Allowance for Japanese Patent Application No. 2013-037053
dated Jan. 6, 2015, 3 pages. cited by applicant .
Office Action for Australian Patent Application No. 2010282523,
dated May 6, 2014, 4 pages. cited by applicant .
Office Action for Canadian Patent Application No. 2,659,772, dated
Oct. 30, 2013, 3 pages. cited by applicant .
Office Action for Canadian Patent Application No. 2,659,772, dated
Sep. 11, 2014, 2 pages. cited by applicant .
Office Action for Chinese Patent Application No. 20180045471.4,
dated May 21, 2014, 6 pages. cited by applicant .
Office Action for Chinese Patent Application No. 201080045471.4,
dated Sep. 29, 2013, 4 pages. cited by applicant .
Office Action for Chinese Patent Application No. 201280012003.6,
dated Jun. 30, 2014, 9 pages. cited by applicant .
Office Action for Chinese Patent Application No. 201280021431.5,
dated Sep. 22, 2014, 3 pages. cited by applicant .
Office Action for Chinese Patent Application No. 201310474149.9,
dated Jan. 27, 2015, 10 pages. cited by applicant .
Office Action for European Patent Application No. 07836471.8, dated
Jul. 13, 2010, 7 pages. cited by applicant .
Office Action for European Patent Application No. 10808724.8, dated
Jan. 15, 2015, 4 pages. cited by applicant .
Office Action for Indian Patent Application No. 654/DELNP/2009,
dated Jul. 31, 2014, 4 pages. cited by applicant .
Office Action for Israeli Patent Application No. 218020, dated Dec.
1, 2013, 12 pages. cited by applicant .
Office Action for Japanese Patent Application No. 2012-524855,
dated Apr. 14, 2014, 7 pages. cited by applicant .
Office Action for Japanese Patent Application No. 2012-524855,
dated Oct. 24, 2014, 5 pages. cited by applicant .
Office Action for Japanese Patent Application No. 2013-037053,
dated Mar. 17, 2014, 5 pages. cited by applicant .
Office Action for Korean Patent Application No. 10-2009-7003220,
dated Oct. 28, 2013, 6 pages. cited by applicant .
Office Action for Korean Patent Application No. 10-2014-7005383,
dated May 14, 2014, 6 pages. cited by applicant .
Shanghai Dongyue Medical Health Product Co Ltd. (2005). Silicon-gel
Membrane--Scar Bandage, located at
<http://www.shdongyue.com/cp/shaos/shaos02b.asp>, last
visited on Nov. 6, 2008, two pages. cited by applicant .
Smith & Nephew. (Date Unknown). "CICA-CARE. Silicone Gel
Sheeting," located at
<http://wound.smith-nepehew.com/za/Product/asp?NodeId=569&Tab=5&hide=T-
rue>, last visited on Jun. 9, 2009, one page. cited by applicant
.
Wound Care Technologies. (2008). "DERMACloseTM RC: Continuous
External Tissue Expander, Brochure No, PL-0020-F," located at <
http://www.woundcaretech.com/sell-sheet.pdf>, last visited on
Sep. 10, 2009, two pages. cited by applicant .
Wound Care Technologies. (2008). "Instructions for Use.
DERMACloseTM RC, Brochure No. DR-0079-A," located at <
http://www.dermaclose.com/instructions.pdf>, last visited on
Sep. 10, 2009, two pages. cited by applicant .
Written Opinion of the International Searching Authority dated Jun.
28, 2012, for PCT Application No. PCT/US2012/027618, filed Mar. 2,
2012, 10 pages. cited by applicant .
Written Opinion of the International Searching Authority dated May
29, 2012, for PCT Application No. PCT/US2012/25510, filed on Feb.
16, 2012, 8 pages. cited by applicant .
Decision to Grant for Chinese Patent Application No.
201280012003.6, dated Feb. 3, 2015, 2 pages. cited by applicant
.
Intention to Grant for European Patent Application No. 12752239.9
dated Sep. 24, 2015, 5 pages. cited by applicant .
Notice of Allowance for Australian Patent Application No.
2010282523, dated Jul. 2, 2015, 2 pages. cited by applicant .
Notice of Allowance for Israel Patent Application No. 218020, dated
Dec. 11, 2014, 4 pages. cited by applicant .
Office Action for European Patent Application No. 07836471.8, dated
Nov. 6, 2015, 7 pages. cited by applicant .
Office Action for Australian Patent Application No. 2012204174,
dated Aug. 4, 2015, 2 pages. cited by applicant .
Office Action for Chinese Patent Application No. 201280021431.5
dated Jul. 17, 2015, 4 pages. cited by applicant .
Office Action for Chinese Patent application No. 201310474149.9,
dated Jul. 27, 2015, 10 pages. cited by applicant .
Office Action for Japanese Patent Application No. 2013-548594,
dated Jul. 7, 2015, 6 pages. cited by applicant .
Office Action for Japanese Patent Application No. 2014-123100,
dated May 18, 2015, 1 page. cited by applicant .
Office Action for Japanese Patent Application No. 2014-143959 dated
May 18, 2015, 1 page. cited by applicant .
Office Action in EP Application No. 16205575.0 dated Dec. 10, 2018
cited by applicant .
3M Medical, 3M Medical. (2006). "They Say Every Scar Tells a
Story," 3M HealthCare: St. Paul, MN, one page. cited by applicant
.
Aarabi, et al Aarabi, S. et al. (Oct. 2007). "Mechanical Load
Initiates Hypertrophic Scar Formation Through Decreased Cellular
Apoptosis," The FASEB Journal 21(12):3250-3261 cited by applicant
.
Al-Attar, et al Al-Attar, A. et al. (Jan. 2006). "Keloid
Pathogenesis and Treatment," Plastic and Reconstructive Surgery
117(1): 286-300 cited by applicant .
Angelini, et al et al. (1984). "Comparative Study of Leg Wound Skin
Closure in Coronary Artery Bypass Graft Operations," Thorax
39:942-945. cited by applicant .
Atkinson, et al (Nov. 2005). "A Randomized, Controlled Trial to
Determine the Efficacy of Paper Tape in Preventing Hypertrophic
Scar Formation in Surgical Incisions that Traverse Langer's Skin
Tension Lines," Plastic and Reconstructive Surgery 116(6)
1648-1656. cited by applicant .
Bachert, et al (2003). "Probing Elastic Modulus and Depth of a Two
Layer Human Skin Model with Piezoelectric Cantilevers," Biomedical
Engineering Senior Design Team, Drexel University, 27 pages. cited
by applicant .
Berman, et al. (Mar. 3, 2005). "Keloid and Hypertrophic Scar,"
located at <http://www.emedicine.com/DERM/topic205.htm>, last
visited on Nov. 19, 2007, 23 pages. cited by applicant .
Bunker, Bunker, T.D. (1983). "Problems with the Use of Op-Site
Sutureless Skin Closures in Orthopaedic Procedures," Annals of the
Royal College of Surgeons of England 65:260-262 cited by applicant
.
Burd, et al. (Dec. 2005), "Hypertrophic Response and Keloid
Diathesis: Two Very Different Forms of Scar," Plastic and
Reconstructive Surgery 116(7):150-157 cited by applicant .
Chen, H-H. et al. (Jul. 2001). "Prospective Study Comparing Wounds
Closed With Tape With Sutured Wounds in Colorectal Surgery," Arch.
Surg. 136:801-803. cited by applicant .
Davison, S.P. et al. (Jan. 2006). "Ineffective Treatment of Keloids
with Interferon Alpha-2b," Plastic and Reconstructive Surgery
117(1):247-252. cited by applicant .
Escoffier, C. et al. (Sep. 1989). "Age-Related Mechanical
Properties of Human Skin: An In Vivo Study," J. Invest. Dermatol.
9(3)3:353-357. cited by applicant .
Evans, S.L. et al. (2009). "Measuring the Mechanical Properties of
Human Skin in vivo Using Digital Correlation and Finite Element
Modeling," J. Strain Analysis 44:337-345. cited by applicant .
Fairclough, J.A. et al. (1987). "The Use of Sterile Adhesive Tape
in the Closure of Arthroscopic Puncture Wounds: A Comparison with a
Single Layer Nylon Closure," Annals of the Royal College of
Surgeons of England 69:140-141. cited by applicant .
Gorney, M. (Mar. 2006). "Scar: The Trigger to the Claim," Plastic
and Reconstructive Surgery 117(3):1036-1037. cited by applicant
.
Hof, M. et al. (Jul. 2006). "Comparing Silicone Pressure-Sensitive
Adhesives to Silicone Gels for Transdermal Drug Delivery,"
presented at 33 Annual Meeting and Exposition of the Controlled
Release Society, Vienna, Austria, Jul. 22-26, 2006, seven pages.
cited by applicant .
Koval, K.J. et al. (Oct. 2003). "Tape Blisters Following Hip
Surgery. A Prospective Randomized Study of Two Types of Tape," The
Journal of Bone and Joint Surgery, 85-5(10):1884-1887. cited by
applicant .
Kuo, F. et al. (May 2006). "Prospective Randomized, Blinded Study
of a New Wound Closure Film Versus Cutaneous Suture for Surgical
Wound Closure," Dermatological Surgery 32(5):676-681. cited by
applicant .
Mustoe, T.Aet al. (Nov. 2005). "A Randomized, Controlled Trial to
Determine the Efficacy of Paper Tape in Preventing Hypertrophic
Scar Formation in Surgical Incisions that Traverse Langer's Skin
Tension Lines,"Plastic and Reconstructive Surgery 116.6, 1657-1658.
cited by applicant .
O'Brien, L. et al. (2009). "Silicon Gel Sheeting for Preventing and
Treating Hypertrophic and Keloid Scars," The Cochrane
Collaboration, pp. 1-47. cited by applicant .
Pitcher, D. (Feb. 1983). "Sutureless Skin Closure for Pacemaker
Implantation: Comparison with Subcuticular Suture," Postgraduate
Medical Journal 59:83-85. cited by applicant .
Shirado, et al "Realization of Human Skin-Like Texture by Emulating
Surface Shape Pattern and Elastic Structure," presented at
Symposium on Haptic Interfaces for Virtual Environment and
Teleoperator Systems 2006, Mar. 25-26, 2006, Alexandria, VA, pp.
295-296. cited by applicant .
Sullivan, S.R. et al. (2007). "Acute Wound Care," Chapter 7 in ACS
Surgery: Principles and Practice, 24 pages. cited by applicant
.
Teot, L. (2005). "Scar Control" European Tissue Repair Society,
located at <http://www.etrs.org/bulletin12_1/section11.php>,
last visited on Nov. 30, 2007, 13 pages. cited by applicant .
Vaughan, P. et al. (2006). "Optimal Closure of Surgical Wounds in
Forefoot Surgery: Are Adhesive Strips Beneficial?" Acta Orthop.
Belg. 72(6):731-733 cited by applicant .
Vowden, K. (Mar. 2003). "Wound Management. Policy and Resource
Pack," Bradford Teaching Hospitals NHS Foundation Trust, pp. 1-70.
cited by applicant .
Watson, G.M. (1983). "Op-Site Skin Closure: A Comparison with
Subcuticular and Interrupted Sutures," Annals of the Royal College
of Surgeons of England 65:83-84. cited by applicant .
Webster, D.J.T. et al. (Sep. 1975). "Closure of Abdominal Wounds by
Adhesive Strips: A Clinical Trial," British Medical Journal
20:696-698 cited by applicant .
Westaby, S. (1980). "Evaluation of a New Product for Sutureless
Skin Closure," Annals of the Royal College of Surgeons of England
62:129-132. cited by applicant.
|
Primary Examiner: Lewis; Kim M
Attorney, Agent or Firm: Dorsey & Whitney LLP
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation of U.S. application Ser. No.
14/158,741, filed Jan. 17, 2014, which is a continuation of U.S.
application Ser. No. 13/089,129, filed Apr. 18, 2011 issued as U.S.
Pat. No. 8,674,164 on Mar. 18, 2014, which is a continuation of
U.S. application Ser. No. 12/854,859, filed Aug. 11, 2010 issued as
U.S. Pat. No. 8,592,640 on Nov. 26, 2013, which claims benefit
under 35 U.S.C. .sctn. 119(e) to U.S. Provisional Application Ser.
No. 61/233,122, filed Aug. 11, 2009, U.S. Provisional Application
Ser. No. 61/243,020, filed Sep. 16, 2009, and U.S. Provisional
Application Ser. No. 61/264,205, filed Nov. 24, 2009, all of which
are hereby incorporated by reference in their entirety. This
application is also related to U.S. application Ser. No.
11/888,978, filed Aug. 3, 2007 issued as U.S. Pat. No. 7,683,234 on
Mar. 23, 2010, U.S. patent application Ser. No. 12/358,162, filed
Jan. 22, 2009 issued as U.S. Pat. No. 8,168,850 on May 1, 2012, and
U.S. patent application Ser. No. 12/358,164, filed Jan. 22, 2009
issued as U.S. Pat. No. 8,183,428 on May 22, 2012, which are hereby
incorporated by reference in their entirety.
Claims
What is claimed as new and desired to be protected by Letters
Patent of the United States is:
1. A skin-treatment device, comprising: an elastic sheet structure,
comprising: a first edge; and a second edge opposite the first
edge; a first skin adhesive region positioned on a first surface
between the first edge and second edge and configured to be applied
to an epidermal layer of skin; a first tensioning device attachment
member, comprising a first separate sheet of material coupled to
the elastic sheet structure at a location spaced from the first
edge; and a second tensioning device attachment member, comprising
a second separate sheet of material coupled to the elastic sheet
structure at a location spaced from the second edge.
2. The skin-treatment device of claim 1, wherein the first
tensioning device attachment member is between the first edge and
the first skin adhesive region and the second tensioning device
attachment member is between the second edge and the first skin
adhesive region.
3. The skin-treatment device of claim 1, wherein the first skin
adhesive region comprises a pressure sensitive adhesive.
4. The skin-treatment device of claim 1, wherein the first
tensioning device attachment member facilitates stretching of the
elastic sheet structure.
5. The skin-treatment device of claim 1, wherein the first separate
sheet of material is adhered to the elastic sheet structure.
6. The skin-treatment device of claim 1, wherein the first separate
sheet of material is heat or plasma bonded to the elastic sheet
structure.
7. The skin-treatment device of claim 1, wherein the first separate
sheet of material is chemically bonded to the elastic sheet
structure.
8. The skin-treatment device of claim 1, wherein the wound elastic
sheet structure further comprises perforations configured to
facilitate separation of the inner skin adhesive region.
9. The skin-treatment device of claim 3, wherein the pressure
sensitive adhesive has a release force of at least about 240
kg/m.
10. The skin-treatment device of claim 1, wherein the pressure
sensitive adhesive has a release force of at least about 270
kg/m.
11. The skin-treatment device of claim 1, wherein the pressure
sensitive adhesive has a release force of at least about 300
kg/m.
12. The skin-treatment device of claim 1, wherein the first
tensioning device attachment member and second tensioning device
attachment member are configured to receive a load to strain the
sheet structure to the engineering strain of 40% with a force of at
least about 0.25 Newtons per mm width of the first sheet of
material.
13. The skin-treatment device of claim 1, wherein the elastic sheet
structure has a load per width of at least 0.35 Newtons per mm at
an engineering strain of 60%.
14. The skin-treatment device of claim 13, wherein the elastic
sheet structure has a load per width of no greater than about 2
Newtons per mm at the engineering strain of 60%.
15. The skin-treatment device of claim 13, wherein the elastic
sheet structure has a load per width of no greater than about 0.5
Newtons per mm at the engineering strain of 60%.
16. The skin-treatment device of claim 13, wherein the elastic
sheet structure has a load per width that does not decrease from an
engineering strain of 0% to 60%.
17. The skin-treatment device of claim 13, wherein the elastic
sheet structure has a load per width that increases linearly from a
true strain of 0% to 60%.
18. The skin-treatment device of claim 13, wherein the elastic
sheet structure has a load per width plot that is not convex from a
true strain of 0% to 60%.
19. The skin-treatment device of claim 9, wherein the inner skin
adhesive region comprises a skin adhesive configured to maintain a
substantially constant stress in the range of 200 kPa to about 400
kPa for at least 8 hours when strained to an engineering strain of
30% and attached to a surface.
20. The skin-treatment device of claim 1, wherein the substantially
constant stress varies by less than 5% over at least 8 hours.
Description
BACKGROUND
Scar formation in response to cutaneous injury is part of the
natural wound healing process. Wound healing is a lengthy and
continuous process, although it is typically recognized as
occurring in stages. The process begins immediately after injury,
with an inflammatory stage. During this stage, which typically
lasts from two days to one week (depending on the wound), damaged
tissues and foreign matter are removed from the wound. The
proliferative stage occurs at a time after the inflammatory stage
and is characterized by fibroblast proliferation and collagen and
proteoglycan production. It is during the proliferative stage that
the extracellular matrix is synthesized in order to provide
structural integrity to the wound. The proliferative stage usually
lasts about four days to several weeks, depending on the nature of
the wound, and it is during this stage when hypertrophic scars
usually form. The last stage is called the remodeling stage. During
the remodeling stage the previously constructed and randomly
organized matrix is remodeled into an organized structure that is
highly cross-linked and aligned to increase mechanical
strength.
While the histological features characterizing hypertrophic scars
have been well documented, the underlying pathophysiology is not
well known. Hypertrophic scars are a side effect of excessive wound
healing, and generally result in the overproduction of cells,
collagen, and proteoglycans. Typically, these scars are raised and
are characterized by the random distribution of tissue bundles. The
appearance (i.e., size, shape, and color) of these scars varies
depending on the part of the body in which they form, and the
underlying ethnicity of the person affected. Hypertrophic scars are
very common, and may occur following any full thickness injury to
the skin. Recently, it has been shown in U.S. Patent Application
Publication 2006/0037091 (U.S. patent application Ser. No.
11/135,992 entitled "Method for Producing Hypertrophic Scarring
Animal Model for Identification of Agents for Prevention and
Treatment of Human Hypertrophic Scarring," filed May 24, 2005)
which is hereby incorporated by reference in its entirety, that
mechanical stress may increase hypertrophic scarring in a murine
model.
Keloids are typically characterized as tumors consisting of highly
hyperplastic masses that occur in the dermis and adjacent
subcutaneous tissue in susceptible individuals, most commonly
following trauma. Keloids are often more severe than hypertrophic
scars, since they tend to invade normal adjacent tissue, while
hypertrophic scars tend to remain confined within the original scar
border.
Previous attempts to treat scars and keloids have included surgery,
silicone dressings, steroids, x-ray irradiation, and cryotherapy.
Each of these techniques has disadvantages. Perhaps the biggest
disadvantage is that none of them effectively prevent or ameliorate
the formation of scars or keloids in the first instance. That is,
these techniques have primarily been used to treat scars after they
are already well established.
BRIEF SUMMARY
Devices, kits and methods described herein may be for wound
healing, including the treatment, amelioration, or prevention of
scars and/or keloids by applying and/or maintaining a
pre-determined strain in an elastic skin treatment device that is
then affixed to the skin surface using skin adhesives to transfer a
generally planar force from the bandage to the skin surface.
Applicators are used to apply and/or maintain the strains, and some
of the applicators are further configured to provide at least some
mechanical advantage to the user when exerting loads onto the skin
treatment device.
In one variation, a device for treating a skin surface is provided,
comprising a first device attachment member comprising a first
plurality of outwardly oriented projections, a second device
attachment member comprising a second plurality of outwardly
oriented projections, and a resilient member configured to exert a
separation force between the first and second device attachment
members. The device may further comprise a releasable locking
mechanism configured to maintain the resilient member in a
retracted configuration, and wherein the retracted configuration
may be a strained configuration. The releasable locking mechanism
may comprise a releasable latch, which may be configured to lock at
a pre-determined strain and optionally resist further straining
when locked at the pre-determined strain, or even a plurality of
pre-determined strains. In some variations, the first device
attachment member, the second device attachment member and the
resilient member may be integrally formed.
In another variation, a wound dressing device is provided,
comprising an applicator configured to maintain an attached
dressing in a strained configuration, and wherein the applicator
comprises a first attachment region, a second attachment region,
and an access region between the first and second attachment
regions configured to provide access to an attached dressing when
the dressing is in a strained configuration.
In another variation, a wound dressing is provided, comprising a
silicone sheet structure comprising an upper surface, a lower
surface, a first edge and a second edge opposite the first edge, a
first adhesive region, a second adhesive region spaced apart from
the first adhesive region by a non-adhesive region, a first flap
region located between the first edge and the first adhesive
region, a second flap region located between the second edge and
the second adhesive region, a first applicator attachment site
located between the first flap region and the first adhesive
region, and a second applicator attachment site located between the
second flap region and the second adhesive region. The wound
dressing may further comprise a first release liner releasably
attached to the first adhesive region and the second adhesive
region. In some further variations, the first and/or second flap
regions may be adhesive flap regions, which may have a second
and/or third release liner releasably attached to them,
respectively. The first and second adhesive regions may comprise a
pressure sensitive silicone adhesive with a release force of at
least about 240 kg/m, about 270 kg/m, about 300 kg/m, or about 330
kg/m. The first applicator attachment site comprises a plurality of
attachment openings or a pocket structure. The first release liner
may have a lower surface and an upper surface with a different
surface texture than the lower surface.
In still another variation, a dressing is provided, comprising an
elastic layer comprising an upper surface, a lower surface, a first
edge, a second edge, a first applicator attachment site, a flap
region between the first edge and the first applicator attachment
site, a second applicator attachment site spaced away from the
second edge, and a first adhesive region located on the lower
surface of the elastic layer.
In another variation, a method for treating a wound is provided,
comprising straining an inner region of an elastic bandage between
a first unstrained region and a second unstrained region, wherein
each unstrained region is spaced away from two opposing edges of
the bandage, and attaching the strained inner region of the bandage
to a skin site. The straining of the inner region of the elastic
bandage may be performed before attaching the strained inner region
of the bandage to the skin site. In some further variations,
attaching the strained inner region of the bandage to the skin site
may be performed without attaching the two opposing edges of the
bandage to the skin site. The method may also further comprise
attaching the two opposing edges of the bandage to the skin site
after attaching the inner region of the bandage to the skin site,
reducing peak strain in the attached bandage while increasing peak
strain at the skin site, and/or attaching the two opposing edges of
the bandage to the skin site, which may include straining the
unstrained regions of the bandage before attaching the two opposing
edges of the bandage to the skin site. Straining the inner region
of the unattached elastic bandage may comprise stretching the inner
region of the unattached elastic bandage to a pre-determined
strain.
In one embodiment, a dressing is provided, comprising an elastic
layer comprising an upper surface, a lower surface, a first edge, a
second edge, a first applicator attachment site, a flap region
between the first edge and the first applicator attachment site, a
second applicator attachment site spaced away from the second edge,
and a first adhesive region located on the lower surface of the
elastic layer.
In another embodiment, a method for treating a wound is provide,
comprising straining an inner region of an elastic bandage between
a first unstrained region and a second unstrained region, wherein
each unstrained region is spaced away from two opposing edges of
the bandage, and attaching the strained inner region of the bandage
to a skin site. Straining the inner region of the elastic bandage
may be performed before attaching the strained inner region of the
bandage to the skin site. Attaching the strained inner region of
the bandage to the skin site may be performed without attaching the
two opposing edges of the bandage to the skin site. The method may
further comprise attaching the two opposing edges of the bandage to
the skin site after attaching the inner region of the bandage to
the skin site. The method may further comprise reducing peak strain
in the attached bandage while increasing peak strain at the skin
site. The method may further comprise attaching the two opposing
edges of the bandage to the skin site. The method may further
comprise straining the unstrained regions of the bandage before
attaching the two opposing edges of the bandage to the skin site.
Straining the inner region of the unattached elastic bandage may
comprise stretching the inner region of the unattached elastic
bandage to a pre-determined strain.
In still another embodiment, an incision treatment system is
provided, comprising an elastic member comprising at least two
hook-and-loop regions and at least one skin adhesive region. The
elastic member may be an elastic layer member. The at least one
adhesive region may be located on an opposite surface of the
elastic member than the at least two hook-and-loop regions. Each of
the at least two hook-and-loop regions may be loop-type of
hook-and-loop regions. The elastic member may comprise at least two
skin adhesive regions. The incision treatment system may further
comprise an applicator comprising at least two hook-and-loop
regions complementary to the at least two hook- and loop regions of
the elastic member.
In one embodiment, a system for treating a skin surface is
provided, comprising a tensioning member, comprising a first device
attachment member, a second device attachment member, and a
collapsible structure configured to movably separate the first and
second device attachment members without requiring continuous
application of external force onto the device to maintain
separation of the first and second device attachment members. The
system may further comprise an elastic member configured to attach
to the first and second device attachment members of the tensioning
member. The elastic member may be configured to releasably attach
to the first and second device attachment members of the tensioning
member. The elastic material may have a load per width of at least
0.35 Newtons per mm at an engineering strain of 60%. The elastic
material may have a load per width of no greater than about 2
Newtons per mm at the engineering strain of 60%, about 1 Newtons
per mm at the engineering strain of 60%, about 0.7 Newtons per mm
at the engineering strain of 60%, or no greater than about 0.5
Newtons per mm at the engineering strain of 60%. The system elastic
material may have a load per width that does not decrease from an
engineering strain of 0% to 60%, a load per width plot that
increases linearly from an engineering strain of 0% to 60%, or a
load per width plot that is not convex from an engineering strain
of 0% to 60%. The elastic material may comprise an adhesive
configured to maintain a substantially constant stress in the range
of 200 kPa to about 500 kPa for at least 8 hours when strained to
an engineering strain of 30% and attached to a surface. The elastic
material may comprise an adhesive configured to maintain a
substantially constant stress in the range of 200 kPa to about 400
kPa for at least 8 hours when strained to an engineering strain of
30% and attached to a surface. The substantially constant stress
may vary by less than 10% over at least 8 hours, or by less than 5%
over at least 8 hours. The collapsible structure may comprise two
collapsible supports and two rigid supports. Each of the two
collapsible supports may articulate with both of the two rigid
supports. The two collapsible supports may each comprise two
pivotably connected subsupports. The collapsible structure may
comprise a collapsed state and an expanded state, and in the
collapsed state, each of the pivotably connected subsupports form
an angle of at least 30 degrees with a line that bisects the two
collapsible supports. The system may further comprise a stamping
structure configured to pass a user-exerted force through the
collapsible structure. The stamping structure may comprise a
stamping surface and a resilient member. The resilient member may
be a spring. The two rigid supports may have a substantially
parallel orientation and at least one of the two rigid supports is
configured to translate along a movement axis perpendicular to the
parallel orientation. The collapsible structure may be configured
to provide a mechanical advantage when exerting the separation
force. The mechanical advantage may be provided throughout a
movement range of the collapsible structure, or may be provided
partially through a movement range of the collapsible
structure.
In one embodiment, a tensioning device configured to exert a
separation force to cause a strain in a skin treatment device may
be provided, the tensioning device comprising a tensioning member,
and a first attachment portion configured to releasably attach to a
skin treatment device and a second attachment portion configured to
releasable attach to the skin treatment device, wherein the
tensioning member may be configured to exert a separation force
between the first attachment portion and the second attachment
portion to cause a strain in a skin treatment device attached to
the first and second attachment portions. The tensioning member may
be configured to strain the skin treatment device to an engineering
strain of 40% using a load of at least about 0.25 Newtons per mm
width of the skin treatment device. The load to strain the skin
treatment device to the engineering strain of 40% may be no greater
than about 1 Newton per mm width of the skin treatment device, and
may be no greater than about 0.5 Newton per mm width of the skin
treatment device. In other embodiments, the tensioning member may
be configured to strain the skin treatment device to an engineering
strain of 60% using a load of at least about 0.35 Newtons per mm
width of the skin treatment device. The load to strain the skin
treatment device to the engineering strain of 60% may be no greater
than about 1 Newton per mm width of the skin treatment device. The
tensioning member may comprise a resilient member configured to
exert the separation force. The tensioning device may further
comprise a compressing member configured to retract the resilient
member to a first configuration and then to release the resilient
member to a strained configuration whereby a strain may be produced
in a skin treatment device attached to the first and second
attachment portions. The tensioning device may further comprise a
releasable locking mechanism configured to releasably lock the
resilient member in the first configuration. The locking mechanism
may be configured to lock across a range of resilient member
configurations corresponding to a range of predetermined strains in
the skin treatment device. The locking mechanism may be configured
to lock across a range of predetermined strains within a range from
about 0% to about 60%, or a range from about 10% to about 50%. The
tensioning member may comprise a mechanical force applicator
configured to exert the separation force. The mechanical force
applicator may provide a mechanical advantage to apply the force.
The mechanical force applicator may be manually actuatable. At
least one the first and second attachment portions may comprise a
hook and loop mechanism. At least one of the first and second
attachment portions may comprise an extension member configured to
be received in an opening in a skin treatment device. At least one
of the first and second attachment portions may comprise an opening
for receiving an attachment member of a skin treatment device. At
least one of the first attachment portion and the second attachment
portion may be configured to move relative to the tensioning member
to facilitate separation of the skin treatment device. At least one
of the first attachment portion and the second attachment portion
may be configured to pivot or rotate relative to the tensioning
member. At least one of the first attachment portion and the second
attachment portion may be configured to retract relative to the
tensioning member. The tensioning device may be an applicator
configured to permit a user to apply a skin treatment device to
skin of a subject. The tensioning device may further comprise
pressure pads configured to apply pressure to a skin treatment
device being applied to skin of a subject. The pressure pads may be
located between the first and second attachment portions. The
tensioning member may have a curved configuration, which may also
be a curved planar configuration. The tensioning member may be
configured to automatically lock upon deformation to a
predetermined locking configuration.
In another embodiment, a method of applying a treatment device to a
surface is provided, comprising actuating the tensioning device to
strain a treatment device to at least a predetermined strain
threshold, maintaining a strain in the treatment device without
requiring external application of force onto the tensioning device,
applying the strained treatment device to a treatment site, and
detaching the treatment device from the tensioning device. The
method may further comprise attaching the treatment device to the
tensioning device before actuating the tensioning device. Actuating
the tensioning device may comprise squeezing the tensioning device.
The method may further comprise relieving at least some of the
strain in the treatment device. Relieving at least some of the
strain in the treatment device may comprise collapsing the
tensioning device. The method may further comprise locking the
tensioning device to a predetermined configuration actuating the
tensioning device. Locking the tensioning device may occur
automatically after straining the treatment device to the
predetermined strain threshold. Relieving the strain may comprise
in the treatment device may comprise unlocking a locking mechanism
of the tensioning device. Attaching the treatment device to the
tensioning device may comprise attaching the treatment device to
the tensioning device may occur at two separate locations using two
attachment mechanisms located on the tensioning device. The method
may further comprise pressing the treatment device against the
treatment site. Pressing the treatment device may occur before
detaching the treatment device from the tensioning device. Pressing
the treatment device may comprise pushing down a resilient stamper
mechanism located between the two attachment mechanisms of the
tensioning device, or reaching into an access opening in the
tensioning device to manually push on the treatment device.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1A is a schematic superior view of one variation of a wound
treatment device; FIG. 1B is a schematic side elevational view of
the wound treatment device in FIG. 1A;
FIGS. 2A and 2B are schematic superior and side elevational views
of the wound treatment in FIGS. 1A and 1B, respectively, with
release liners; FIG. 2C is a superior component view of the release
liners in FIGS. 2A and 2B;
FIG. 3A is a perspective view of a wound treatment applicator in a
base configuration; FIGS. 3B to 3D are side elevational, superior
and inferior views of the applicator in FIG. 3A;
FIGS. 4A to 4D are perspective, side elevational, superior and
inferior views of the applicator in FIGS. 3A to 3D in a locked
configuration;
FIGS. 5A and 5B are schematic perspective and side elevational
views of the applicator in FIGS. 4A and 4B loaded with a wound
treatment device;
FIG. 6 depicts another variation of an applicator;
FIG. 7 schematically depicts another variation of an applicator
with two sets of central panels and locking mechanisms;
FIG. 8 schematically depicts another variation of an applicator
with hinged base structures;
FIG. 9 schematically depicts another variation of an applicator
with bendable wire-supported base structures;
FIG. 10 is a schematic front elevational view of a curved
attachment structure of an applicator;
FIGS. 11A and 11B are schematic side elevational views of an
applicator with a hinged frame in an unlocked and locked
configuration, respectively.
FIG. 12A is a schematic superior view of an applicator with
pneumatic strut members;
FIG. 12B is a schematic component view of the ratchet locking
mechanism of the applicator in FIG. 12A; and
FIGS. 13A to 13D schematically depict one variation of the use of
the wound treatment device depicted in FIGS. 1A and 1B.
FIGS. 14A and 14B illustrate engineering and true stress/strain
plots, respectively, of STERI-STRIP.TM. material.
FIGS. 15A and 15B illustrate engineering and true stress/strain
plots, respectively, of BAND-AID.RTM. Flexible Fabric backing
material.
FIGS. 16A and 16B illustrate engineering and true stress/strain
plots, respectively, of an intact BAND-AID.RTM. Flexible Fabric
bandage.
FIGS. 17A and 17B illustrate engineering and true stress/strain
plots, respectively, of BAND-AID.RTM. TOUGH STRIP.TM. backing
material.
FIGS. 18A and 18B illustrate engineering and true stress/strain
plots, respectively, of an intact BAND-AID.RTM. TOUGH STRIP.TM.
bandage.
FIGS. 19A and 19B illustrate engineering and true stress/strain
plots, respectively, of NEXCARE.TM. TEGADERM.TM. backing
material.
FIGS. 20A and 20B illustrate engineering and true stress/strain
plots, respectively, of an intact NEXCARE.TM. TEGADERM.TM.
bandage.
FIGS. 21A and 21B illustrate engineering and true stress/strain
plots, respectively, of one embodiment of a backing material
configured to impose a skin strain using a predetermined strain in
the backing material.
FIGS. 22A and 22B illustrate engineering and true stress/strain
plots, respectively, of elastic Steri-Strip.TM. material.
FIGS. 23A and 23B illustrate engineering and true stress/strain
plots, respectively, of BAND-AID.RTM. ULTRA STRIP.RTM. backing
material.
FIGS. 24A and 24B illustrate engineering and true stress/strain
plots, respectively, of an intact BAND-AID.RTM. ULTRA STRIP.RTM.
bandage.
FIGS. 25A and 25B illustrate engineering and true stress/strain
plots, respectively, of DuoDERM.RTM. Extra Thin material.
FIGS. 26A and 26B illustrate engineering and true stress/strain
plots, respectively, of CVS/Pharmacy.RTM. silicone scar sheet
backing material.
FIGS. 27A and 27B illustrate engineering and true stress/strain
plots, respectively, of CVS/Pharmacy.RTM. self-adherent gentle wrap
material.
FIGS. 28A and 28B illustrate engineering and true stress/strain
plots, respectively, of DuoDERM.RTM. CGF.RTM. material.
FIGS. 29A and 29B illustrate engineering and true stress/strain
plots, respectively, of CVS/Pharmacy.RTM. elastic bandage
material.
FIGS. 30A to 30C depict load per width plots of various bandage
materials using three different Y-axis scales, respectively.
FIGS. 31A and 31B are engineering stress plots over time for the
Nexcare.TM. Tegaderm.TM. under different loads using different
X-axis scales, respectively.
FIGS. 32A and 32B are engineering stress plots over time for the
GLYDe-M device under different loads using different X-axis scales,
respectively.
FIGS. 33A and 33B are engineering stress plots over time for the
elastic Steri-Strip.TM. under different loads using different
X-axis scales, respectively.
FIGS. 34A and 34B are engineering stress plots over time for
Band-Aid.RTM. Ultra Strip.RTM. backing material under different
loads using different X-axis scales, respectively.
FIGS. 35A and 35B are engineering stress plots over time for the
Band-Aid.RTM. Flexible Fabric under different loads using different
X-axis scales, respectively.
FIGS. 36A and 36B are engineering stress plots over time for
CVS/Pharmacy.RTM. silicone scar sheeting under different loads
using different X-axis scales, respectively.
FIGS. 37A and 37B are engineering stress plots over time for
DuoDERM.RTM. Extra Thin under different loads using different
X-axis scales, respectively.
FIGS. 38A and 38B are engineering stress plots over time for
DuoDERM.RTM. CGF.RTM. under different loads using different X-axis
scales, respectively.
FIGS. 39A and 39B are engineering stress plots over time for
CVS/Pharmacy.RTM. elastic bandage under different loads using
different X-axis scales, respectively.
FIGS. 40A and 40B are engineering stress plots over time for the
CVS/Pharmacy.RTM. self-adherent gentle wrap under different loads
using different X-axis scales, respectively.
FIGS. 41A and 41B illustrate engineering and true stress/strain
plots, respectively, of Smith & Nephew OpSite.TM..
FIGS. 42A to 42C are superior, cross sectional and side elevational
views of a dressing comprising pockets.
FIGS. 43A to 43C are cross sectional views of alternate embodiments
of a dressing comprising pockets.
FIGS. 44A and 44B are superior and cross sectional views of another
dressing comprising T-tag attachment structures.
FIGS. 45A and 45B are superior and cross sectional views of another
dressing comprising eyelet attachment structures.
FIGS. 46A to 46C are superior, cross sectional and side elevational
views of another dressing comprising a hook-and-loop type of
attachment structure.
FIG. 47 depicts an applicator with corresponding hook-and-loop type
of attachment structures configured for use with the dressing in
FIGS. 46A to 46C.
FIG. 48 depicts another applicator with corresponding hook-and-loop
type of attachment structures configured for use with the dressing
in FIGS. 46A to 46C.
FIGS. 49A to 49B depicts another applicator with hook-and-loop type
of attachment structures.
FIG. 50A is a perspective view of an applicator in an unstrained
configuration; FIG. 50B is a perspective view of the applicator of
FIG. 50A in a strained configuration; FIG. 50C is a side
elevational view of a handle and locking mechanism of the
applicator of FIG. 50A in an unstrained configuration; FIG. 50D is
a side elevational view of a handle and locking mechanism of the
applicator of FIG. 50A in a strained configuration; FIG. 50E is a
superior view of the applicator of FIG. 50A in a strained
configuration; and FIG. 50F is a side elevational view of the
applicator of FIG. 50A in a strained configuration.
FIG. 51A is a perspective view of an applicator in an unstrained
configuration; FIG. 51B is a perspective view of the applicator of
FIG. 51A in a strained configuration; FIG. 51C is a anterior view
of the applicator of FIG. 51A in an unstrained configuration; FIG.
51D is a front side view of an applicator of FIG. 51A in a strained
configuration.
FIG. 52A is a perspective view of an applicator in an unstrained
configuration; FIG. 52B is a perspective view of the applicator of
FIG. 52A applicator in a strained configuration; FIG. 52C is an
inferior view of the applicator of FIG. 52A in an unstrained
configuration; FIG. 52D is an inferior view of the applicator of
FIG. 52A in a strained configuration; FIG. 52E is a superior view
of the applicator of FIG. 52A in an unstrained configuration; FIG.
52F is a superior view of the applicator of FIG. 52A in a strained
configuration; FIG. 52G is a cross-sectional view of the applicator
of FIG. 52E along the lines A-A in an unstrained configuration; and
FIG. 52H is a cross-sectional view of an applicator of FIG. 52F
along the lines B-B in a strained configuration.
FIG. 53A is a perspective view of an applicator in an unstrained
configuration; FIG. 53B is a perspective view of the applicator of
FIG. 53A applicator in a strained configuration; FIG. 53C is an
inferior view of the applicator of FIG. 53A in an unstrained
configuration; FIG. 53D is an inferior view of the applicator of
FIG. 53A in a strained configuration; and FIG. 53E is a superior
view of the applicator of FIG. 53A in a strained configuration.
FIG. 54A is a superior view of an applicator in an unstrained
configuration; FIG. 54B is a superior view of the applicator of
FIG. 54A in a strained configuration; FIG. 54C is an inferior
perspective view of the applicator of FIG. 54A in an unstrained
configuration; FIG. 54D is an inferior perspective view of the
applicator of FIG. 54A in a strained configuration; FIG. 54E is a
perspective view of the applicator with integrated stamper, in an
unstrained configuration; FIG. 54F is a perspective view of the
applicator of FIG. 54E in a strained configuration; FIG. 54G is a
side view of the applicator of FIG. 54E in an unstrained
configuration; FIG. 54H is a side view of the applicator of FIG.
54E in a strained configuration; and FIG. 54I is a side view of the
applicator of FIG. 54E in a strained configuration with a deployed
stamper.
FIG. 54J is a schematic illustration and equation to determine the
mechanical advantage of a collapsing box applicator design; FIG.
54K is a table listing the input load and output load of one
embodiment of a collapsing box applicator for strains from 0% to
40%; FIG. 54L is a graph of the input and output loads per strain
of the data from FIG. 54K; FIG. 54M is a table listing the input
load and output load of another embodiment of a collapsing box
applicator for strains from 0% to 60%; FIG. 54N is a graph of the
input and output loads per strain of the data from FIG. 54M up to
40% strain; FIG. 54O is a table listing the input load against a
constant output load of the collapsing box applicator embodiment
from FIGS. 54M and 54N for strains from 0% to 60%; FIG. 54P is a
graph of the input and output loads per strain of the data from
FIG. 54O;
FIG. 55A is a perspective view of an applicator with an integrated
foam stamper in an unstrained configuration; FIG. 55B is a
perspective view of the applicator of FIG. 55A in a strained
configuration; FIG. 55C is a side partial cut-away view of the
applicator of 55A in an unstrained configuration; FIG. 55D is an
inferior view of the applicator of FIG. 55A in a strained
configuration; and FIG. 55E is an inferior view of the applicator
of FIG. 55A in a strained configuration
FIG. 56A is a perspective view of an applicator with an integrated
foam stamper in an unstrained configuration; FIG. 56B is a
perspective view of the applicator of FIG. 56A in a strained
configuration; FIG. 56C is a perspective view of the tensioning
device of the applicator of FIG. 56A in an unstrained
configuration; FIG. 56D is a perspective view of the tensioning
device of the applicator of FIG. 56A in a strained configuration;
and FIG. 56E is a side cross sectional view of the applicator of
FIG. 56A in an unstrained configuration.
FIG. 57A is a perspective view of an applicator with an integrated
foam stamper in an unstrained configuration; FIG. 57B is a
perspective view of the applicator of FIG. 57A in a strained
configuration; FIG. 57C is an inferior view of the tensioning
device of the applicator of FIG. 57A in an unstrained
configuration; FIG. 57D is an inferior view of the tensioning
device of the applicator of FIG. 57A in a strained configuration;
FIG. 57E is a front elevational view of the tensioning device of
the applicator of FIG. 57A in an unstrained configuration; FIG. 57F
is a cross sectional view of the device as indicated in FIG. 57E;
FIG. 57G is a side elevational view of the tensioning device of the
applicator of FIG. 57A in a strained and stamped configuration;
FIG. 57H is a cross sectional view of the device as indicated in
FIG. 57G; and FIG. 57I is a partial cut-away perspective view of
the tensioning device of the applicator of FIG. 57A in a strained
configuration.
FIG. 58A is a perspective view of an applicator in an unstrained
configuration; FIG. 58B is a side view of the applicator of FIG.
58A in an unstrained configuration; FIG. 58C is a side view of the
applicator of FIG. 58A in a strained configuration; FIG. 58D is a
side view of the applicator of FIG. 58A in a strained and stamped
configuration; FIG. 58E is a superior view of the applicator of 58A
in a strained, stamped and unreleased configuration; FIG. 58F is a
cross-sectional view of the applicator of FIG. 58E along the lines
A-A; FIG. 58G is a superior view of the applicator of 58A in a
strained, stamped and released configuration; FIG. 58H is a
cross-sectional view of the applicator of FIG. 58G along the lines
A-A; and FIG. 58I is a cross-sectional view of the applicator of
FIG. 58G along the lines B-B.
FIG. 59A is a perspective view of an applicator in an unstrained
configuration; FIG. 59B is a side view of the applicator of FIG.
59A in an unstrained configuration; FIG. 59C is a side view of the
applicator of FIG. 59A in a strained an unstamped configuration;
and FIG. 59D is a side view of the applicator of FIG. 59A in a
strained and stamped configuration.
FIG. 60A is a perspective view of an applicator and skin treatment
device in an unstrained configuration; FIG. 60B is a perspective
view of the applicator and skin treatment device of FIG. 60A in a
strained configuration; FIG. 60C is a perspective view of the
applicator and skin treatment device of FIG. 60A in an applied and
released configuration; and FIG. 60D is a perspective view of an
applicator with an integrated foam stamper in an unstrained
configuration.
FIG. 61A is a perspective view of an applicator in a strained
configuration; FIG. 61B is a perspective view of the applicator of
FIG. 61A in an unstrained configuration with the attachment feet
released (unconstrained); FIG. 61C is a superior view of the
applicator of FIG. 61A in a strained configuration; FIG. 61D is a
side cross section view across the lines A-A of a portion of the
applicator of FIG. 61C; FIG. 61E is a superior view of the
applicator of FIG. 61A in an unstrained configuration; and FIG. 61F
is a side cross sectional view across the lines A-A of a portion of
the applicator of FIG. 61E.
FIG. 62A is a perspective view of an applicator and skin treatment
device in an unstrained configuration; FIG. 62B is a perspective
view of the applicator and skin treatment device of FIG. 62A in a
released configuration; FIG. 62C is a perspective view of the
applicator and skin treatment device of FIG. 62A in a strained
configuration; and FIG. 62D is a perspective view of the applicator
and skin treatment device of FIG. 62A in an applied
configuration.
FIG. 63A is a perspective view of a variation of an attachment
system in an unloaded configuration; and FIG. 63B is a perspective
view of a variation of the attachment system of FIG. 63A in a
loaded configuration.
FIGS. 64A to 64Q illustrate variations of an attachment system.
FIG. 65A is a perspective view of an attachment structure system in
a first position; FIG. 65B is a side view of the attachment
structure system of FIG. 65A in the first position; and FIG. 65C is
a side view of the attachment structure system of FIG. 65A in a
second, retracted position.
FIG. 66A is a superior view of a skin treatment device in a first
position; and FIG. 66B is a superior view of the skin treatment
device of FIG. 66A in a second position.
DETAILED DESCRIPTION
The mechanical environment of an injury may be an important factor
in tissue response to that injury. The mechanical environment
includes exogenous stress (i.e., physiological stress which
includes stress transferred to the wound via muscle action or
physical body movement) and endogenous stress (i.e., dermal stress
originating from the physical properties of the skin itself,
including stress induced at the wound site due to swelling or
contraction of the skin). The devices, bandages, kits and methods
described herein may control or regulate the mechanical environment
of a wound to ameliorate scar and/or keloid formation. The
mechanical environment of a wound includes stress, strain, and any
combination of stress and strain. The control of a wound's
mechanical environment may be active or passive, dynamic (e.g., by
applying an oscillating stress) or static. The stresses and strains
acting on the wound may involve the layers of the skin, such as the
outer stratum corneum, the epidermis and dermis, as well as the
underlying connective tissue layers, such as the subcutaneous fat.
Devices and methods described here may shield a wound from its
mechanical environment. The term "shield" is meant to encompass the
unloading of stress experienced by the wound as well as providing a
physical barrier against contact, contaminants, and the like. The
devices and methods described here may shield a wound by unloading
the wound and surrounding tissues from endogenous stress and/or
exogenous stress. Thus, devices and methods described here may
reduce the stress experienced by a wound and surrounding tissues to
a lower level than that experienced by normal skin and tissue.
Unloading of exogenous and/or endogenous stress in the vicinity of
the wound may ameliorate the formation of scars, hypertrophic
scars, or keloids.
A cell's external mechanical environment may trigger biological
responses inside the cells and change cell behavior. Cells can
sense and respond to changes in their mechanical environment using
integrin, an integral membrane protein in the plasma membrane of
cells, and intracellular pathways. The intracellular pathways are
initiated by receptors attached to cell membranes and the cell
membrane that can sense mechanical forces. For example, mechanical
forces can induce secretion of cytokines, chemokines, growth
factors, and other biologically active compounds that can increase
or trigger the inflammatory response. Such secretions can act in
the cells that secrete them (intracrine), on the cells that secrete
them (autocrine), on cells surrounding the cells that secrete them
(paracrine), or act at a distance from the point of secretion
(endocrine). Intracrine interference can alter cell signaling,
which can in turn alter cell behavior and biology including the
recruitment of cells to the wound, proliferation of cells at the
wound, and cell death in the wound. In addition, the extracellular
matrix may be affected.
As noted above, the wound healing process may be characterized in
three stages: early inflammatory phase, the proliferative phase,
and remodeling. The inflammatory phase occurs immediately after
injury and typically lasts about two days to one week. Blood
clotting takes place to halt blood loss and factors are released to
attract cells that can remove debris, bacteria and damaged tissue
from the wound. In addition, factors are released to initiate the
proliferative phase of wound healing. In the proliferative phase,
which lasts about four days to several weeks, fibroblasts grow and
build a new extracellular matrix by secreting collagen and
proteoglycans. At the end of the proliferative phase, fibroblasts
can act to contract the wound further. In the remodeling phase,
randomly oriented collagen is organized and crosslinked along skin
tension lines. Cells that are no longer needed can undergo
apoptosis. The remodeling phase may continue for many weeks or
months, or indefinitely after injury. Scars typically reach about
75-80% of normal skin breaking strength about 6-8 weeks after
injury. In general, scars typically have a triangular
cross-section. That is, a scar is usually smallest in volume near
the skin surface (i.e., stratum corneum and epidermis) and
increases in volume as it progresses into the deeper layers of the
dermis.
There are three common possible outcomes to a wound healing
process. First, a normal scar can result. Second, a pathologic
increase in scar formation can result, such as formation of a
hypertrophic scar or a keloid. Third, the wound may not heal
completely and become a chronic wound or ulcer. The devices, kits
and methods described herein can ameliorate the formation of any
type of scar. In addition, the devices, kits and methods described
here can be adapted for a variety of wound sizes, and for different
thicknesses of skin, e.g., the devices may be configured for use in
different areas of the body. In addition, the devices, kits and
methods described here can be adapted to ameliorate scar formation
in any type of skin, e.g., body location, age, race, or
condition.
Without wishing to be bound by any particular theory, we believe
that mechanical strain acting on a wound or incision early in the
proliferative phase of the wound healing process may inhibit
cellular apoptosis, leading to a significant accumulation of cells
and matrix, and hence increased scarring or the production of
hypertrophic scars. Given the underlying similarities between
hypertrophic scars and keloids with respect to excessive matrix
formation, we believe that the devices and methods described herein
may also be useful in preventing and treating keloids by offloading
or neutralizing at least some of the strain that may be acting on
the wound or incision. This tensile strain may be exogenous and/or
endogenous strain, and may include but is not limited to the strain
from the intrinsic tensile forces found in normal intact skin
tissue.
Devices are described here for ameliorating the formation of scars
and/or keloids at a wound site. The scars may be any type of scar,
e.g., a normal scar, a hypertrophic scar, etc. In general, the
devices may be configured to be removably secured to a skin surface
near a wound. The devices may shield the wound from endogenous
stress and/or exogenous stress. In some variations, the devices may
shield the wound from endogenous stress without affecting exogenous
stress on the wound, e.g., devices that modify the elastic
properties of the skin, etc. In other variations, the devices may
shield the wound from exogenous stress without affecting endogenous
stress on the wound. Such variations may include situations where
the musculature and surrounding wound tissue has been paralyzed,
e.g., through the use of botulinum toxin or the like. In still
other variations, the devices shield the wound from both endogenous
and exogenous stress.
The devices, dressings and bandages described herein may ameliorate
the formation of scars at wound sites by controllably stressing or
straining the epidermis and deeper layers of dermal tissue around
the wound, thereby reducing tensile or compressive stress at the
wound site itself. The stress at the wound site may be reduced to
levels below that experienced by normal skin and tissue. The stress
or strain may be applied to surrounding tissue in one, two, or
three directions to reduce endogenous or exogenous stress at the
wound in one, two or three directions.
The physical characteristics of the device and/or the method of
applying the device may also be further configured to resist or
reduce the rate of skin stripping or tension blistering from the
application of strain to the incision site.
FIGS. 1A and 1B depict one variation of a wound treatment device 2,
comprising an elastic layer of material 4 with an upper surface 6,
a lower surface 8, and edges 10, 12, 14 and 16. The lower surface 8
of the elastic layer of material 4 may comprise a central
non-adhesive region 18 flanked by two inner adhesive regions 20 and
22 along borders 24 and 26. In this particular variation, the
central non-adhesive region 18 also has two borders 28 and 30 which
are adhesive-free. This configuration may facilitate the treatment
of longer incisional sites by serially placing the non-adhesive
regions of multiple wound treatment devices along the incisional
site, without the device edges directly adhering to the incisional
site.
In some variations, the average width of the non-adhesive region,
i.e. the distance between the adhesive regions along the axis of
strain (or where the device is strained along multiple dimension,
the largest dimension of the device 2 along one of its axes of
strain), is in the range of about 3 mm to about 15 mm or more, in
some variations about 5 mm to about 10 mm, and in other variations
about 7 mm to about 8 mm. The width of the adhesive region may be
the same or greater than the width of the non-adhesive regions,
including but not limited to being 2.times., 3.times., or 4.times.
or more in relative width. In some variations, the greater width of
the adhesive regions relative to the non-adhesive region may lower
focal concentrations of tissue stress, which may reduce tissue
stripping and/or blistering. The widths of the non-adhesive region
and/or the adhesive regions may be constant or may be variable, and
the widths of the adhesive regions may be the same or
different.
The inner adhesive regions 20 and 22 may comprise outer borders 32
and 34 which are opposite of the inner borders 24 and 26 shared
with the central non-adhesive region 18 and shared with the outer
non-adhesive regions 36 and 38. The non-adhesive regions 36 and 38
may further comprise applicator attachment regions or structures 40
and 42 that are configured to releasably attach to an applicator
that may be used to apply the device 2 to a treatment site. In some
further variations, the attachment structures may also facilitate
stretching of the central adhesive region 18 and/or the adhesive
regions 20 and 22. Various examples of applicators that may be used
are described in greater detail below. In other variations, the
applicator attachment structures 40 and 42 may be located in
adhesive regions that may or may not be contiguous with more inner
adhesive regions. In other variations, the elastic material about
the attachment structures may comprise an adhesive. Examples of
applicators are described in greater detail below.
The applicator attachment structures 40 and 42 may comprise a
plurality of openings 44 and 46 located through the layer of
elastic material 4. The openings 44 and 46 may be through-openings
between the upper and lower surfaces. In other variations, the
openings may be close-ended openings, e.g. a plurality of pockets
or even a single pocket spanning the width or a portion of the
width of the device.
In the variation depicted in FIGS. 1A and 1B, the openings 44 and
46 are configured to be fully penetrated by the applicator, but in
other variations, the applicator and/or the openings may be
configured for only partial insertion by the applicator. The
openings 44 and 46 may be circular, ovoid, triangular, rectangular,
square, polygonal or any other of a variety of shapes. Each of the
openings may have the same or a different shape, size or
configuration, and the shape, size or configuration may vary
between the upper surface and the lower surface. The openings may
be also be angled with respect to the upper surface or lower
surface, and in some variations, one or more openings and/or a
region about the openings may be partially or completely reinforced
by wires, rings and/or frames and the like. In some variations, the
applicator attachment structures may also comprise denser or
thicker regions of the elastic material. In some variations,
multiple sets of applicator attachment structures may be provided
to permit use of different applicators or to strain the device to
different degrees, for example.
FIGS. 42A to 42C depict another variation of the dressing 600
comprising pockets 602 and 604 with inwardly facing pocket openings
606 and 608 configured to receive the attachment structures of a
corresponding applicator. The pockets may comprise separate sheets
of material that are attached to the elastic material and may
comprise the same or a different material as the other portions of
the dressing. The separate sheets of material may be adhered to the
elastic material using adhesives, heat or plasma bonding, chemical
bonding or mechanical attachment structures (e.g. staples and
stitches). In the example depicted best in FIGS. 42B and 42C, the
pockets 602 and 604 may be integrally formed structures of the base
layer 610 that are folded over from the ends 612 and 614 of the
dressing 600 and attached onto itself along the edges 616 and 618
without bonding the opening edge 620 to form the opening 606. In
other variations, such as the dressing 630 depicted in FIG. 43A,
the inner portions 632 of a pocket structure 634 or the distal edge
636 may also be adhered or fused to form multiple subpockets 638
and 640. Although FIG. 43A depicts a dressing with two subpockets
638 and 640, in other variations, three, four, five, six, seven,
eight or more subpockets may be provided. The area or width of the
fused inner portion(s) 652 may also vary, as shown in the dressing
650 in FIG. 43B. The width of the fused inner portion(s) may be in
the range of about 0.5 mm to about 10 mm or more, sometimes about 1
mm to about 5 mm, and other times about 1 mm to about 2 mm. As
shown in the dressing 660 of FIG. 43C, in other variations, the
subpockets 662 and 664 may also be separately provided without an
inner portion interconnecting them. In some further variations, the
opening(s) of the pocket structures may be closed or sealed shut
after application. Closure may result from using an adhesive,
complementary sealable groove structures about the pocket openings
(e.g. sandwich bag seal) or as a result of the cohesive properties
of the elastic material when the pocket is pressed down. Closure of
the pockets may reduce the risk of snagging the dressing following
its application.
In other variations, the applicator attachment structures may
comprise one or more projections or other structures protruding
from the surface of the wound treatment device that form a
mechanical or frictional interfit with the applicator. Referring to
FIGS. 44A to 45B, examples of these alternate attachment structures
include T-bar 672 or eyelet projections 682 of the dressings 670
and 680 that may be releasably engaged by an applicator. The t-bar
672 and eyelet projections 682 may be integrally formed with the
base elastic layer 674 and 684 of the dressings 670 and 680, or may
comprise a different material that is partially embedded in the
elastic layer 674 and 684. In still other variations, the t-bar or
eyelet projections may comprise individual or common base or pad
structures that may be adhered to the surface of the elastic layer
674 and 684. The number of projecting attachment structures per
side of the dressing may be in the range of about one to about
twelve or more, sometimes about three to about eight, and other
times about four to about five.
In still another variation, the dressing may comprise complementary
hook-and-loop attachment regions (e.g. VELCRO.RTM.) that may
releasably attach to an applicator with a corresponding
hook-and-loop attachment regions. In FIGS. 46A to 46C, for example,
the bandage 700 comprises loop attachment regions 702 and 704 that
are adhered to the upper surface 706 of the bandage 700, and with
various adhesive regions 708a/b and 710a/b located on the lower
surface 712. In use, a corresponding applicator, including but not
limited to the exemplary applicator 714 depicted in FIG. 47, is
squeezed or compressed to reduce the spacing between corresponding
hook regions 716 and 718 to correspond to the spacing of the loop
attachment regions 702 and 704 of the bandage 700 in its
unstretched state. The hook regions 716 and 718 are aligned and
then pressed against the loop attachment regions 702 and 704 to
engage the bandage 700. In some examples, the applicator 714 may
comprise a locking mechanism 720 to maintain the applicator 714 in
a compressed state during engagement of the bandage 700, but in
other examples, such as the applicator 730 in FIG. 48, the user
will manually maintain the applicator 730 in a compressed state to
align its hook regions 732 and 734 to the loop regions 702 and 704
to engage the bandage 700. A locking mechanism is not used. In some
alternate application procedures, the applicator 714 (or 730) is
not squeezed and instead, one of the loop regions 702 and 704 of
the bandage 700 is first attached to a corresponding hook region
716 or 718, for example, and then the bandage 700 may be stretched
and the remaining loop region 702 or 704 is attached to the
applicator 714.
Although the examples in FIGS. 46A to 48 illustrate the loop
regions 702 and 704 on the bandage 700 and the hook regions 716 and
718 located on the applicator 714, for example, in other
variations, the relative relationships between the hook and the
loop attachment regions may be reversed. The hook-and-loop
attachment regions may be provided on any of the variety of
dressing applicators the variety of applicators described herein.
FIGS. 49A and 49B, for example, illustrate an applicator 750 that
is a variation of the applicator 220 depicted in FIGS. 12A and 12B,
but with hook and loop regions 752 on the force members 754 instead
of the plurality of projections. Applicator 220 is described in
greater detail below.
In some variations, one or more flap regions 48 and 50 may be
provided adjacent to the outer non-adhesive regions 36 and 38, or
the applicator attachment structures 40 and 42. Each of the flap
regions 48 and 50 may be located directly between an edge 10 and 12
of the treatment device 2 and the outer non-adhesive regions 36 and
38 or applicator attachment structures 40 and 42. During use or
preparation of the treatment device 2 for application to the skin,
the flap regions 48 and 50 may remain unstretched relative to the
central non-adhesive region 18 and inner adhesive regions 20 and
22. Once the adhesive regions 20 and 22 are adhered to the skin,
the flap regions 48 and 50, which may optionally also comprise an
adhesive on their skin contacting surface, may be adhered to the
skin. The flap regions may be adhered to the skin in an unstrained
state, or in a strained state that is less than, equal to, or
greater than the strain in the central non-adhesive region 18 and
adhesive regions 20 and 22. In still other variations, the flap
regions may be cut or separated from the dressing after the
dressing is applied. Perforations may be provided between the
adhesive regions and the flap regions to facilitate separation.
The adhesive provided on the lower surface of the flap regions 48
and 50 may be the same or may be different than the adhesive of the
inner adhesive regions 20 and 22, including but not limited to the
composition, thickness and/or distribution of the adhesive
material. In some variations, the adhesive of the flap regions 48
and 50 may have a reduced T-peel release force and/or blunt probe
tack force relative to the adhesive provided for the inner regions
20 and 22. Various T-peel release force and/or blunt probe tack
force ranges for the adhesive are provided below. In some
variations, the unstrained or less-strained flap regions may
redistribute at least some of the strains acting on tissue about
the transition regions along the outer borders 32 and 34 of the
inner adhesive regions 20 and 22. This may or may not reduce the
risk of skin stripping or blistering compared to devices without
flap regions or with flap regions of smaller width. In some
variations, the actual width of a section of the flap region or the
average width of the flap region or (or adhesive portion of the
flap region) may be characterized relative to the corresponding
width of the closest inner adhesive region and/or the width of the
closest outer non-adhesive region. The width of the flap region may
be in the range of about 1 mm to about 10 cm or more, sometimes
about 5 mm to about 3 cm, and other times about 1 cm to about 2 cm.
The size of the flap region may be also characterized relative to
the size of the other regions of the dressing. For example, in some
variations, the width of the flap region may be at least about 25%,
about 33%, about 50%, about 75%, about 100%, or about 120% or
higher than the corresponding width of the closest inner adhesive
region. The width of the flap region relative to the closest outer
non-adhesive region may be at least about 50%, about 75%, about
100%, about 120% or higher.
The stretching of the adhesive regions when applied to the skin
surface may result in an increased tissue density under the
adhesive region. This may be the result of generally planar,
tangential or parallel compression of skin tissue that is directly
attached to that adhesive region, resulting from the relaxation of
the adhesive region. In some examples, this tissue compression may
reduce the risk of tissue stripping and/or blistering of skin in
direct contact with the adhesive, in contrast to bandage
"strapping" where one end of a bandage is adhered to the skin and
then tensioned or pulled across a wound before the other end is
attached to the skin on the opposite side of the wound.
Furthermore, bandage "strapping", while generating tension in the
bandage during the application, may simultaneously generate a
relatively high tissue strain at the first adhesion site. This high
tissue strain then decreases when the bandage is attached to the
skin at a second adhesion site as the high peak stresses are
redistributed along the skin under the bandage. In contrast, when a
pre-strained bandage is applied to the skin, little if any strain
may be transferred or generated in the skin as the adhesive regions
are applied to the desired locations. When the pre-strained bandage
is permitted to relax, however, the strain (or peak strain) in the
skin may be increased. Thus, with a pre-strained bandage, temporary
high tissue strain may be avoided or otherwise reduced during the
application procedure. In other variations, however, the device 2
may also be applied to the skin by strapping, or by a combination
of pre-straining and strapping.
Although the depicted wound treatment device 2 may have a generally
rectangular configuration with a size of about 80 mm to about 40
mm, in other variations the device may have any of a variety of
lengths and widths, and may comprise any of a variety of other
shapes. Also, the corners of the device may be squared or rounded,
for example. The lengths and/or widths of the device may be in the
range of about 5 mm to about 1 meter or more, in some variations
about 20 mm to about 500 mm, and in other variations about 30 mm to
about 50 mm, and in still other variations about 50 mm to about 100
mm. In some variations, the ratio of the maximum dimension of the
wound device (e.g. its length) to an orthogonal dimension to the
maximum dimension (e.g. width), excluding the minimum dimension of
the device (e.g. the thickness), may be in the range of about 1:1,
about 2:1, about 3:1, about 4:1 about 5:1, about 6:1, about 7:1,
about 8:1, about 9:1 or about 10:1 or greater. In some variations,
the strain axis of the device in use may be oriented with respect
to the maximum dimension or to the orthogonal dimension to the
maximum dimension.
The elastic material of the device may comprise a single layer of
material or multiple layers of the same or different materials. The
material may have any of a variety of configurations, including a
solid, foam, lattice, or woven configuration. The elastic material
may be a biocompatible polymer, e.g., silicone. The thickness of
polymer sheets, e.g., silicone polymer sheets or shape memory
polymer sheets, may be selected to provide the devices or bandages
with sufficient load carrying capacity to achieve desired
recoverable strains, and to prevent undesired amounts of creep
deformation of the bandages or devices over time. In some
variations, the thickness across devices or bandages is not
uniform, e.g., the thickness across the device may be varied to
change the stiffness, the load carrying capacity, or recovery
strains in selected orientations and/or locations. The elastic
material may have a thickness in the range of about 50 microns to 1
mm or more, about 100 microns to about 500 microns, about 120
microns to about 300 microns, or in some variations about 200
microns to about 260 microns. In some examples, devices having an
edge thickness of about 500 microns or less, 400 microns or less,
or about 300 microns or less may exhibit less risk of skin
separation from inadvertent lifting when inadvertently brushed
against clothing or objects. In some variations, the devices or
bandages are tapered near the edges to reduce thickness. A tapered
edge may also ameliorate peak tensile forces acting on skin tissue
adjacent to the adhesive edges of the wound treatment device. This
may or may not reduce the risk of skin blistering or other
tension-related skin trauma. In other variations, the edges of the
devices or bandage may be thicker than the middle of the device or
bandage. It is hypothesized that in some configurations, a thicker
device or bandage edge may provide a relative inward shift of the
location of the peak tensile forces acting near the device or
bandage edge, compared to devices or bandages of uniform
thickness.
The adhesive regions may comprise a pressure sensitive adhesive,
e.g., polyacrylate-based, polyisobutylene-based, silicone-based
pressure sensitive adhesives, and the like. The T-peel release
force and blunt probe tack force of the adhesive may be measured by
a standardized test method, such as ASTM D1876 and ASTMD2979 or
other appropriate method. In some variations, the T-peel release
force or blunt probe tack test value of the adhesive is configured
to maintain loads of at least about 50 mPa/mm for at least about 24
hours, about 48 hours, about 72 hours, about 1 week, about 2 weeks,
about 3 weeks, about 4 weeks or more. In other variations, the
loads may be at least about 75 mPa/mm, about 100 mPa/mm, about 125
mPa/mm, or at least about 150 mPa/mm over the particular time
period. The degree of adhesion (e.g. as measured by the T-peel
release force or blunt probe tack test value) may vary depending
upon the degree of strain placed onto the skin or incision site,
and in some variations, these time periods may be based upon an
average skin strain of about 10%, about 20%, about 30%, about 40%,
or about 50% or more. In some variations, the adhesive may have a
T-peel release force of at least about 150 kg/m, about 160 kg/m,
about 170 kg/m, about 180 kg/m, about 190 kg/m, about 200 kg/m,
about 210 kg/m, about 220 kg/m, about 230 kg/m, about 240 kg/m,
about 250 kg/m, about 260 kg/m, about 270 kg/m, about 280 kg/m,
about 290 kg/m, about 300 kg/m, about 310 kg/m, about 320 kg/m,
about 330 kg/m, about 340 kg/m, about 350 kg/m, about 400 kg/m,
about 450 kg/m, or at least about 500 kg/m or higher. In some
further variations, the T-peel release force may be no greater than
about 1000 kg/m, about 900 kg/m, about 800 kg/m, about 700 kg/m,
about 600 kg/m, about 500 kg/m, about 400 kg/m or about 300 kg/m.
The blunt probe tack test value of the adhesive may be at least
about 0.50 kg, about 0.55 kg, about 0.60 kg, about 0.65 kg, about
0.70 kg or about 0.75 kg or higher, and may be no greater than
about 1 kg, about 0.9 kg, about 0.8 kg, about 0.7 kg, or about 0.6
kg. The T-peel release force and blunt probe tack force may be
measured by a standardized test method, such as ASTM D1876 and
ASTMD2979 or other appropriate method. Other features or variations
of the device are described in U.S. application Ser. No.
11/888,978, filed on Aug. 3, 2007, which was previously
incorporated by reference.
In some variations, the final compressive stress and strain imposed
onto the skin by the elastic material 4 may be the result of the
dynamic equilibrium between the tensile stress in the skin and the
elastic material 4 of the wound treatment device 2. Referring to
FIGS. 13A to 13D, the skin at incision site 90 typically comprises
an inherent tension 96a that stretches incision site 90, whether or
not any tissue was excised from the incision site 90. The elastic
material 4 and the adhesive region 18 may be configured to be
applied to a skin location so that when the device 2 is stretched
to a particular tension 94a and then adhered to the incision site
90, tensile stress in the device 2 is transferred to the incision
site 90 to compress the tissue directly under the device 2 along a
tangential axis 98 to the skin surface 99, the stress and strain
imposed onto the skin location has a net or resultant orientation
or axis is also generally tangential or planar to the elastic
material 4 and/or the outer surface of the skin location, with a
similar axis to the orientation or axis of the tensile stress in
the device 2. The tension 94a in the device 2 will relax to a
tension level 94b that maintains equilibrium with increased tension
96b in the skin adjacent to the device 2. The application of the
device 2 to the skin location may involve the placement of the
device 2 without overlapping or being wrapped onto itself, e.g.
wherein only adjacent regions of the device 2 are interconnected
and wherein non-adjacent regions of the device 2 are not
interconnected. The actual amount of stress and strain imposed on
the skin may vary, depending upon the particular person, skin
location, the thickness or various mechanical characteristics of
the skin layers (e.g. epidermis, dermis, or underlying connective
tissues), and/or the degree of pre-existing scarring, for example.
In some further variations, the wound treatment device 2 may be
selected or configured for use at a specific body location, such as
the scalp, forehead, cheek, neck, upper back, lower back, abdominal
region, upper torso (including but not limited to the breast
folds), shoulder, upper arm, lower arm, palm regions, the dorsum of
the hand, finger, thigh, lower leg, the dorsum or plantar surface
of the foot, and/or toe. Where applicable, some body regions may be
further delineated into anterior, posterior, medial, lateral,
proximal and/or distal regions, e.g. the arms and legs.
The wound treatment device 2 may be configured to impose a skin
strain in the range of about 10% to about 60% or more, in other
configurations about 15% to about 50%, and in still other
configurations, about 20% to about 30% or about 40%. To achieve the
desired degree of skin strain, the wound treatment device 2 may be
configured to undergo elastic tensile strain in the range of about
20% to about 80% or more, sometimes about 30% to about 60%, and
other times about 40% to about 50% or about 60%. The device 2 may
comprise any of a variety of elastic materials, including but not
limited to silicones, styrenic block copolymers, natural rubbers,
fluoroelastomers, perfluoroelastomers, polyether block amides,
thermoplastic elastomers, thermoplastic polyurethane, polyisoprene,
polybutadiene, and the like. The material may have a Shore A
durometer in the range of about 20 to about 90, about 30 to about
80, about 50 to about 80. One example of the elastic material 4 is
MED 82-5010-05 by NUSIL TECHNOLOGY LLC (Carpinteria, Calif.). Other
examples of suitable materials are described in U.S. application
Ser. No. 11/888,978, which was previously incorporated by reference
in its entirety.
When the strained device 2 is applied to a skin location and
allowed to at least partially recover to its base configuration,
the recovery level or equilibrium level of strain in the device may
be in the range of about 10% to about 60% or more, in other
configurations about 15% to about 50%, and in still other
configurations, about 20% to about 30% or about 40%. The ratio
between the initial engineering tensile strain placed onto the
device 2 before recovery and the resulting engineering compressive
strain in the skin may vary depending upon the skin type and
location, but in some examples, may be about 2:1. In other
examples, the ratio may be in the range of about 4:1 to about 5:4,
about 3:1 to about 5:3, or about 5:2 to about 2:1. These skin
strain characteristics may be determined with respect to a
reference position of the body or body part, e.g. anatomical
position, to facilitate reproducible measurements. The particular
degree of strain may be characterized as either an engineering
strain or a true strain, but may or may not be calculated based
upon or converted from the other type of strain (e.g. the strain
may be based upon a 60% engineering strain that is converted to a
true strain).
In some further variations, one or more characteristics of the
elastic material 4 may correspond to various features on the
stress/strain curve of the material 4. In FIGS. 21A and 21B, for
example, the engineering and true stress/strain curves 400 and 402,
respectively, for one specific example of the wound treatment
device (GLYDe-M) is depicted. As illustrated in FIG. 21A, the
device comprises a material that exhibits an engineering stress 404
of about 1.2 MPa at about 60% engineering strain, but in other
examples, the engineering stress may be in the range of about 900
KPa to about 2.5 MPa, about 1 MPa to about 2.2 MPa, about 1 MPa to
about 2 MPa, about 1.1 MPa to about 1.8 MPa, about 1.1 MPa to about
1.5 MPa, about 1.2 MPa to about 1.4 MPa. When unloading or
relieving stress from the device 2, the material 4 may be
configured with an engineering stress of about 380 KPa at about 40%
engineering strain 406, but in other examples, the engineering
stress during unloading of the material 4 to about a 40% strain may
be in the range of about 300 KPa to about 700 KPa, about 325 KPa to
about 600 KPa, about 350 KPa to about 500 KPa, or about 375 KPA to
about 425 KPa. When unloading the material 4 to an engineering
strain 408 of about 30%, the material exhibits an engineering
stress of about 300 KPa, but in other examples, the engineering
stress when unloading the material 4 to about 30% strain may be in
the range of about 250 KPa to about 500 KPa, about 275 KPa to about
450 KPa, about 300 KPa to about 400 KPa, or about 325 KPA to about
375 KPa. When unloading to an engineering strain 410 of about 20%,
the material may have an engineering stress of about 100 KPa, but
in other examples, the unloading engineering stress at about 20%
may be in the range of about 50 KPa to about 200 KPa, about 75 KPa
to about 150 KPa, or about 100 KPa to about 125 KPa. In some
examples, the material 4 may be configured to at least achieve a
specific range or level of engineering stress at each of the
specified engineering strain levels described above, but in other
examples, the material 4 may be configured for lower levels of
maximum engineering strain, e.g. up to about 30% or about 40%.
In some examples, certain portions of the stress/strain curve may
have a particular morphology. For example, for a particular level
of maximum strain the loading curve may be generally linear on the
corresponding true stress/strain curve. As illustrated in FIG. 21B,
up to a true strain 412 of about 45%, the loading curve 414 has a
generally linear configuration. In other examples, the
configuration may only be linear along a portion of the loading
curve or may be curved along the entire loading curve. Where the
loading curve is non-linear, the loading curve may be convex,
concave or both. Also, in some examples, the tangent line 416 of
the loading curve 414 (i.e. the line between the two triangles) may
also be generally co-linear.
In some variations, the elastic material 4 comprises a material
having an elastic modulus E of at least about 1 MPa, about 1.5 MPa,
about 2 MPa, about 2.5 MPa, about 3 MPa, about 3.5 MPa, about 4
MPa, about 5 MPa, about 6 MPa, about 7 MPa, about 8 MPa, about 9
MPa or at least about 10 MPa or greater. The material elastic
modulus E may be no greater than about 10 MPa, about 9 MPa, about 8
MPA, about 7 MPa, about 6 MPa, or about 5 MPa, or about 4 MPa.
In addition to the absolute stress levels at certain strain levels
described above, the material may also be characterized with
respect to the ratio between a) the stress to achieve a particular
strain during loading, and b) the stress at the same strain during
unloading. For example, the material may have a ratio of at least
4:1 to about 3:2 at each of the 20%, 30% and 40% strain levels, but
in other examples, the material may exhibit these ratios only at
20%, at 30%, or at 40% strain levels, or at both 20% and 30% but
not 40%, or at both 30% and 40% but not 20%. In other examples, the
ratio at one, some or all of the strain levels may be in the range
of about 3:1 to about 2:1, or about 5:2 to about 2:1.
In some examples, the elastic material of the device 2 may be
configured under testing conditions to achieve a stable level of
stress at a constant strain, e.g. the material exhibits a limited
amount of stress relaxation over a particular period of time and at
a particular level of strain. The period of time may be at least
about 8 hours, about 12 hours, about 18 hours, about 24 hours,
about 36 hours, about 48 hours, about 72 hours, about 4 days, about
5 days, about 6 days, or about a week or more. The level of strain
may be about 10%, about 20%, about 30%, about 40%, about 50%, about
60%, about 70%, or about 80% or more. FIGS. 32A and 32B illustrate
the stress of the GLYDe-M device over various time curves 418 and
420, respectively. Specifically in FIG. 32B, the GLYDe-M device is
configured to maintain an engineering stress of about 300 KPa at an
engineering strain of about 30% without noticeable deviation over a
period of about 1 hour, about 2 hours, about 3 hours, about 4
hours, about 5 hours, about 6 hours, about 7 hours, or about 8
hours or more. The stresses at 10% strain, 20% strain, and at 40%
may be lower or higher. A comparator line 422 is provided to
illustrate the strain level between the two curves 418 and 420.
In some variations, the elastic material or the device may be
configured under testing conditions to maintain a particular
minimum level of stress when held at a constant strain over a
particular time period. To assess the ability of a backing material
to maintain a stress and strain on skin over time, engineering
strains were measured while each backing material was tensile
strained to 60% at a rate of 100 microns per second and held for 10
minutes, and then dropped to a strain of 30% at a rate of 100
microns per second and held for 9 hours. In FIGS. 32A and 32B, for
example, the GLYDe-M device is able to maintain an engineering
stress level of about 350 KPa at an engineering strain of 30%. In
some other examples, the minimum level of stress may be about 100
KPa, about 120 KPa, about 140 KPa, about 160 KPa, about 180 KPa,
about 200 KPa, about 220 KPa, about 240 KPa, about 260 KPa, about
280 KPa, about 300 KPa, about 320 KPa, about 340 KPa, about 360
KPa, about 380 KPa, about 400 KPa, about 420 KPa, about 440 KPa,
about 460 KPa, about 480 KPa, about 500 KPa, about 600 KPa, about
700 KPa, about 800 KPa, about 900 KPa or about 1000 KPa or greater.
The level of constant strain may be different in other
configuration, with a level of about 15%, about 20%, about 25%,
about 30%, about 35%, about 40%, about 45%, about 50%, about 55%,
about 60%, about 65%, about 70%, about 75%, or about 80%. The time
period over which the device is able to maintain a stress level may
be at least about 2000 seconds, about 3000 seconds, about 4000
seconds, about 5000 seconds, about 6000 seconds, about 7000
seconds, about 8000 seconds, about 9000 seconds, about 10000
seconds, about 20000 seconds, about 30000 seconds, about 40000
seconds, about 50000 seconds, about 60000 seconds, about 70000
seconds, about 24 hours, about 36 hours, about 48 hours, about 72
hours, about 4 days, about 5 days, about 6 days, about 7 days,
about 10 days, about 2 weeks, about 1 month or more. In some
variations, the device 2, the elastic material 4 and/or the
adhesive material is configured to exhibit less than about a 15%
change in stress or strain level over the particular period when
applied to a skin surface or test surface. In other examples, the
degree of change may be about 12%, about 10%, about 8%, about 6%,
about 5%, about 4%, about 3%, or about 2% or less. The stress or
strain may be an engineering stress or strain, and/or a true stress
or strain.
Materials Testing
A variety of commercially available bandages were evaluated along
with one specific example of a wound treatment device (GLYDe-M) to
assess various force loading and recovery properties. Where the
commercially available bandage comprised a backing material along
with an absorbent pad, the bandage was tested both as an intact
bandage, and also with the absorbent pad carefully removed to
isolate the properties of the backing material. The following
commercially available bandages were tested along with the GLYDe-M
system:
TABLE-US-00001 TABLE 1 Product Thickness Manufacturer Product
(backing only)* -- Wound treatment device (GLYDe-M) 0.26 mm 3M (St.
Paul, MN) Steri-Strip .TM. (regular) 0.15 mm 3M (St. Paul, MN)
Steri-Strip .TM. (elastic) 0.27 mm CVS/Pharmacy .RTM. Self-Adherent
Wrap (generic) 1 mm J&J (New Brunswick, NJ) BAND-AID .RTM.
Flexible Fabric 0.32 mm J&J (New Brunswick, NJ) BAND-AID .RTM.
Tough Strip 0.18 mm J&J (New Brunswick, NJ) BAND-AID .RTM.
Ultra Strip 0.23 mm 3M Nexcare .TM. (St. Paul, MN) Tegaderm .TM.
0.05 mm ConvaTec (Skillman, NJ) DuoDERM .RTM. Extra Thin 0.49 mm
ConvaTec (Skillman, NJ) DuoDERM .RTM. CGF .RTM. 2 mm CVS/Pharmacy
.RTM. Elastic Bandage (generic) 0.88 mm CVS/Pharmacy .RTM. Silicone
Scar Sheet (generic) 0.64 mm *and adhesive, if any.
The above bandages underwent testing to assess their material
properties with respect to their stress-strain curves. Each of the
bandages was tensile strained to an engineering strain of 60% and
then permitted to recover. To simulate conditions at least somewhat
similar to use on human skin, the testing was performed at a
temperature of 33 degrees Celsius and at a humidity of 50%. In some
examples, use of elevated temperatures and/or humidity may better
reflect real-world performance of the device or bandage when
applied to a person. The measurements of the engineering stress and
engineering strain were also calculated as true stress/strain
curves and were also used to calculate the initial elastic modulus
of the material.
Referring to FIGS. 14A and 14B, the stress-strain curves for a
regular Steri-Strip.TM. demonstrated that the material failed to
strain to 60%. As shown in the curve 500 in FIG. 14A, the
Steri-Strip.TM. resulted in rupture 502 before reaching an
engineering strain of 35%. Other evidence of structural failure
included the downsloping, irregular segments 504 along the loading
portion of the curve 500. Furthermore, substantial levels of
engineering stresses of almost 15 MPa were needed to achieve an
engineering strain of only about 5%. In some variations, use of
high stresses to strain the wound treatment device may pose a
safety risk to the user and/or the patient. Although the force used
to strain a device will vary based upon the elastic modulus,
thickness and width of the device, in some variations, the elastic
modulus of the material used in the wound treatment device may be
in the range of about 1 MPa to about 10 MPa, in some variations
about 2 MPa to about 8 MPa, in other variations about 3 MPa to
about 5 MPa, and in still other variations in the range of about 3
MPa to about 4 MPa. In some instances, a higher elastic modulus may
generate a greater risk of skin blistering.
Referring to FIGS. 15A and 15B, some backing materials, such as the
flexible fabric used in Flexible Fabric BAND-AIDS.RTM., are unable
to impose substantial loads onto the skin when the backing material
is strained and then permitted to recover the strain. As shown in
the curve 510 in FIG. 15A, although the flexible fabric of this
BAND-AID.RTM. was able to reach an engineering strain of 60%, upon
unloading, engineering strains 512 fell quickly, and upon recovery
to strains of 30% and 20%, respectively, the flexible fabric
material was unable transfer significant forces 514 and 516,
respectively, to the skin. This substantial difference may or may
not reflect damage to the underlying material. As shown in FIGS.
16A and 16B, an intact Flexible Fabric BAND-AID.RTM. also had a
stress-strain curve 520 with a recovery portion of the 322 in FIG.
16A showing substantial drop-off and limited residual force at
strains 524 and 526 at 30% and 20%, respectively.
Another example of a material that failed to elastically strain to
60% is the backing material of Tough Strip.TM. BAND-AID.RTM.. As
depicted in the engineering stress-strain curve 530 in FIG. 17A,
structural damage is demonstrated by the downsloping, irregular
segment 532 of the curve 530 during loading, with the peak
engineering stress 534 occurring at about 40% strain rather than
60% strain. Relative to the peak engineering stress 534, or the
corresponding loading stresses 536 and 538 at 20% and 30%, the
recovery stresses 540 and 542 at 20% and 30% also illustrate that
this material may be inefficient at transferring loads to the skin.
As further depicted in FIGS. 18A and 18B, the stress-strain curves
of an intact Tough Strip.TM. BAND-AID.RTM. continue to show
evidence of structural damage at even earlier levels of strain.
Although the stress-strain curves depicted herein reflect certain
intrinsic properties of the materials used in the tested bandages,
the stress-strain curves alone may not be indicative of the
suitability of a particular bandage to impose a strain on a skin
location. The amount of stress and strain imposed on the skin may
also vary depending upon the thickness, width, length, elastic
modulus, and other material characteristics of the wound treatment
device, as well as the amount of stress and strain placed on the
wound treatment device. The force F exerted by the device may be
generally characterized by the following equation, where E is the
elastic modulus of the elastic material 4, A0 is cross-sectional
area of the elastic material 4 transverse to the direction of
stress, L0 is the initial length of the elastic material along the
direction of stress and .DELTA.L is the change in the length:
F=EA.sub.0.DELTA.L/L.sub.0
This force may also be characterized in terms of the force per
width of the elastic material 4:
.times..DELTA..times..times..times..DELTA..times..times.
##EQU00001##
In one example depicted in FIGS. 19A and 19B, the stress-strain
curves 550 and 552 for Nexcare.TM. Tegaderm.TM. occlusive bandages
are provided. Although these curves do not indicate evidence of
damage or rupture when loaded to 60% engineering strain 554 (or
corresponding true strain 556), as did the Steri-Strip.TM.,
Flexible Fabric BAND-AID.RTM. and Tough Strip.TM. BAND-AID.RTM.,
when the bandages are characterized in terms of their load-carrying
capacity, as shown in FIG. 30C, Tegaderm.TM. exhibited
substantially lower loads per millimeter width than many other
tested bandages. Thus, the ability of some bandages to impose a
stress onto the skin to generate skin strain may be limited. Also,
as explained in greater detail below, many elastic materials was
unable to sustain consistent levels of stress over time. This may
be the result of stress relaxation in the backing material which
was not intended to be strained to 30% as tested.
The stress-strain curves of still other bandages are provided in
FIGS. 22A to 29B and 41A and 41B. Many of these bandages comprise
materials with stress-strain curves that involve lower levels of
stress, that result in lower load carrying capacity, as shown in
FIG. 30C, while other bandages comprise materials that exhibit
significant stress relaxation or other decreased in the strain
imposed on the skin over time. As shown in FIG. 31A, the
Nexcare.TM. Tegaderm.TM. backing material initially generated an
engineering stress 560 of about 750 KPa when dropped to a strain of
30%, but over the course of 9 hours, the level engineering stress
562 continued to decrease, as shown in FIG. 31B with comparator
line 564. In some examples, the backing material may be configured
so that the engineering stress is tested at an engineering strain
of 30% or some other level of strain over a period of time, the
engineering stress levels decreases by less than about 15%, about
10%, about 8%, about 6%, about 5%, about 4%, about 3%, about 2%, or
about 1% or less, or even effectively 0% for a particular time
period.
The other backing materials tested generated an engineering stress
of about 200 KPa or less at an engineering strain of 30% and/or
demonstrated a decrease in the engineering stress over 9 hours, as
depicted in FIGS. 34A to 40B. In some variations, this may indicate
that the particular bandage may not be configured to generate
consistent forces sufficient to impose sufficient stresses onto the
skin to decrease skin tension, including high skin tension regions
of the body such as the back and face.
For example, as shown in FIGS. 33A to 34B, both the elastic
Steri-Strip.TM. and the BAND-AID.RTM. ULTRA STRIP.RTM. generated an
initial engineering strain of around 200 KPa at 30% strain, but
also demonstrated at least some decrease in stress over time, with
the ULTRA STRIP.RTM. decreasing more than the elastic
Steri-Strip.TM.. These decreases may be even greater if tested over
longer periods of time, such as about 12 hours, about 24 hours,
about 36 hours, about 48 hours, about 72 hours, about 96 hours,
about 1 week, about 2 weeks, about 3 weeks, or about 4 weeks or
greater, for example. As shown in FIGS. 35A to 40B, the backing
materials of the other bandages generated substantially less than
200 KPa engineering stress, and some materials such as the
DuoDERM.RTM. CGF.RTM., the CVS/Pharmacy.RTM. elastic bandage, and
the self-gripping CVS/Pharmacy.RTM. self-adherent gentle wrap,
generated less than 50 KPa. Even at these lower levels of stress,
however, some of the backing materials were unable to sustain
consistent engineering stress levels over 9 hours, such as shown in
FIGS. 37B, 38B, and 39B for DuoDERM.RTM. Extra Thin, DuoDERM.RTM.
CGF.RTM. and CVS/Pharmacy.RTM. elastic bandage, respectively. Of
further note is that the two bandages configured to be stretched
when applied to the body, the CVS/Pharmacy.RTM. elastic bandage and
the CVS/Pharmacy.RTM. self-adherent gentle wrap, are both designed
to be wrapped circumferentially around a body part and to be
attached back onto itself, exhibited the lowest engineering
stresses when strained to 30%. This is also illustrated in FIG.
30C, where the portions of the unloading curves at 30% true strain
are the lowest among the tested bandages, and at 20% true strain,
are among the lowest along with DuoDERM.RTM. Extra Thin.
In addition to testing of the mechanical properties of the backing
materials, the adhesive properties of the commercial bandages were
also assessed. The testing was performed only with the bandages
that had at least some adhesiveness or tackiness that permits
measurement of slippage when applied to a test surface, excluding
the CVS/Pharmacy.RTM. self-adherent gentle wrap and the
CVS/Pharmacy.RTM. elastic bandage. Also, bandages that could not be
elastically strained to 20% engineering strain, such as a regular
Steri-Strip.TM. and the BAND-AID.RTM. Tough Strip, were excluded.
To test the remaining materials, the backing material of each
bandage was trimmed to a sample size of approximately 12
mm.times.50 mm. Each sample was stretched to either an engineering
strain of 20% or 40% and then applied to polycarbonate sheeting and
the degree of slippage was observed up to 48 hours. Although the
intrinsic properties of each adhesive used with each bandage may
not be directly comparable based on this testing due to substantial
differences in engineering stress generated at the specified levels
of strain, and/or the degree of stress relaxation exhibited by each
material, such testing may provide at least some indication of
existing bandages to impose stresses onto skin.
TABLE-US-00002 TABLE 2 Slippage at Slippage at Manufacturer Product
20% Strain 40% Strain -- Wound treatment device None @ None @
(GLYDe-M) 48 hrs. 48 hrs. 3M (St. Paul, MN) Steri-Strip .TM.
(elastic) None @ None @ 22 hrs. 22 hrs. J&J BAND-AID .RTM.
Flexible None @ Slight @ 24 hrs (New Brunswick, NJ) Fabric 46 hrs.
Evident @ 46 hrs J&J BAND-AID .RTM. Ultra Strip Slight @ 24 hrs
Evident @ 2 hrs 40 min (New Brunswick, NJ) 3M Nexcare .TM. Tegaderm
.TM. None @ None @ (St. Paul, MN) 24 hrs. 24 hrs. ConvaTec DuoDERM
.RTM. Extra Thin Slippage @ Slippage @ (Skillman, NJ) 22 hrs. 22
hrs. ConvaTec DuoDERM .RTM. CGF .RTM. Edge peel @ 3 hrs Slippage @
3 hrs (Skillman, NJ) Slippage at 24 hrs More Slippage @ 24 hrs
CVS/Pharmacy .RTM. Silicone Scar Sheet Slippage @ 3 min Slippage @
3 min
As mentioned previously, although the actual force required to
tensile strain a device may vary, depending upon the size of the
device, in some variations, the device may be configured to achieve
an engineering strain of about 60% using a load per millimeter
width that is less than or equal to about 6 Newtons/millimeter
(N/mm), about 5 N/mm, about 4 N/mm, about 3 N/mm, about 2 N/mm,
about 11 N/mm, about 0.8 N/mm, about 0.7 N/mm, about 0.6 N/mm,
about 0.5 N/mm.
Each of the material or structural characteristics above may be
mixed and matched to achieve the desired tensile stress/strain
profile. In one specific example, the elastic material 4 may have
an elastic modulus E in the range of about 2 MPa to about 4 MPa,
exhibits a generally linear or curvilinear stress/strain loading
curve (either engineering stress .sigma./strain e or true stress
.sigma.true/strain .epsilon.) with elastic deformation up to at
least about 60% tensile engineering strain. In other examples, the
elastic deformation property may be limited to about 20%, about
30%, about 40%, or about 50%. The elastic material 4 may also be
configured with an average thickness in the range of about 100
microns to about 500 microns, about 200 microns to about 400
microns, or about 200 microns to about 300 microns. The elastic
material 4 may also be configured to exert a minimum load per
millimeter width at a particular strain. For example, when tensile
strained to an engineering strain of 60%, the elastic material 4
may exert a compressive load/mm of at least about 0.3 N, about 0.35
N, about 0.4 N, about 0.45 N, or at least about 0.5 N. In some
examples, when tensile strained to an engineering strain of 40%,
the elastic material 4 may exert a compressive load/mm of at least
about 1.5 N/mm, about 1.6 N/mm, about 1.7 N/mm, about 1.8 N/mm,
about 1.9 N/mm, about 2 N/mm, about 2.1 N/mm, about 2.2 N/mm or
about 2.3 N/mm, about 2.4 N/mm, about 2.5 N/mm or about 3 N/mm or
greater. In still other examples, when tensile strained to an
engineering strain of 30%, the elastic material 4 may exert a
compressive load/mm of at least about 0.7 N/mm, about 0.8 N/mm,
about 0.9 N/mm, about 1 N/mm, about 1.1 N/mm, about 1.2 N/mm, or
about 1.3 N/mm or greater. In yet other examples, when tensile
strained to an engineering strain of 20%, the elastic material 4
may exert a compressive load/mm of at least about 0.4 N/mm, about
0.45 N/mm, about 0.5 N/mm, about 0.55 N/mm, about 0.6 N/mm, about
0.65 N/mm, or about 0.7 N/mm or greater. On stress measurements at
an engineering strain of about 30%, over a period of at least about
8 hours, about 12 hours, about 24 hours, or about 72 hours, the
engineering strain may be at least about 175 KPa, about 200 KPa or
about 225 KPa with a decrease in engineering strain that is no
greater than about 12%, about 10%, about 8%, about 6%, about 5%,
about 4%, about 3%, about 2% or less than about 1%.
Release Liner
Referring to FIGS. 2A and 2B, the wound treatment device 2 may be
provided with one or more release liners 52, 54 and 56 to protect
one or more of the adhesive regions 20, 22, 48 and 50. The release
liners 52, 54 and 56 may be configured with one or more flaps or
tabs 58, 60, 62, 64, 66 and 68 that project from the edges 10, 12
or surfaces 6, 8 of the treatment device 2 to facilitate grasping
or removal of the release liners 52, 54 and 56. FIG. 2C depicts the
liners 52, 54 and 56 without the wound treatment device 2. In some
examples, the release liners may resist inadvertent adhesion of the
wound treatment device to itself or other surfaces during loading
of the device onto an applicator, or during application of the
device to the skin. In variations where the device has multiple
separate adhesive regions, separate release liners may be provided
for each region, or some regions may be covered by the same release
liner. Referring back to FIGS. 2A and 2B, the three release liners
52, 54 and 56 are provided to cover the four adhesive regions 20,
22, 48 and 50, with two end release liners 52 and 54 covering the
flap regions 48 and 50, respectively and a single release liner 56
covering both inner adhesive regions 20, 22. The end release liners
52 and 54 each comprise two tabs 58 and 60 which project from the
same edge 10 and 12, respectively, of the device, but in other
variations, one or more tabs may project from the other edges 14
and/or 16, from multiple edges, or from no edges. The central
release liner 56, for example, comprises tabs 66 and 68 that
project from opposing edges 10 and 12 of the device. Although the
tabs 58, 60, 62 and 64 are depicted as aligned with the edges 14
and 15 of the treatment device 2, in other variations the liners
may be configured with tabs at other locations, or with a different
number of tabs. In some variations, the tabs may also be folded or
creased, which may facilitate grasping where the tabs are located
against a surface rather than projecting from an edge.
In variations comprising multiple release liners, the liners may or
may not be removed at different times or in a particular order. In
some variations the liners may include indicia to facilitate
removal in a particular order. The indicia may comprise
alpha-numeric characters 70 and 72, color, graphic symbols and the
like, and may be located on the body of the liner or on the tabs,
if any. In FIGS. 2A and 2B, for example, users may be instructed to
remove the central liner 56 during the loading of the treatment
device 2 onto an applicator and/or for application to a skin site.
After the initial adherence of the treatment device 2 to the skin,
the outer release liners 52 and 54 covering the flap regions 48 and
50 may then be removed to permit adherence of the rest of the
treatment device 2.
The release liners may comprise any of a variety of materials,
including both opaque and transparent materials. The release liners
may comprise Mylar or paper, or any other material with reduced
adhesion to the adhesive material(s) of the device. In some
examples, the central liner 56 (or a different liner) may be
reapplied to the inner adhesive regions 20 and 22 after the
treatment device 2 is loaded onto an applicator, which may protect
the adhesive materials until actual application to the skin. The
liners may comprise different surface geometries, e.g. surface
roughness, and/or indicia that may permit identification of the
original liner surface that was applied to the adhesive regions,
which may reduce degradation of the adhesive regions from dust,
dander and/or other substances if the incorrect side of the liner
is reapplied to the device.
Applicator
As noted previously, an applicator, tensioning device and/or
straining device may be provided in some embodiments to impart a
strain to a skin treatment device with an external force and/or to
maintain a strain imparted to the skin treatment device. In some
examples, the straining device may be configured to impart and/or
maintain a single predetermined or pre-set strain or a plurality of
predetermined or pre-set strains. Features described herein with
respect to an applicator may also be used in any tensioning or
straining device that is used to strain a skin treatment device. An
applicator, tensioning or straining device that is described as
being in an unstrained configuration is in a configuration in which
a skin treatment device may be unstrained or relatively less
strained when attached to the applicator, tensioning or straining
device. An applicator, tensioning, or straining device that is
described herein has being in a strained configuration is in a
configuration in which a skin treatment device may be strained or
relatively more strained when attached to the applicator,
tensioning or straining device. Features described herein with
respect to an applicator may also be used in any tensioning or
straining device that is used to strain a skin treatment
device.
A skin treatment device that is described herein is a device that
may be applied, attached to or coupled to one or more layers of the
skin of a subject and may include without be limited to, a wound
treatment device, a dressing, bandage, or other device.
Attachment structures of an applicator, tensioning or straining
device may include any structures that are used to attach or couple
an applicator, tension or straining device to a skin treatment
device. Such devices may include but are not limited to pockets and
tabs, hook and loop mechanism, hooks, angled bars, adhesives,
removable adhesives, pegs, rip cords, towel bar configurations,
sliding pins, friction locks, cam locks, vacuum or suction devices,
snap connectors, carpet tack, press fit connections or other
connections.
The attachment structure profile may be straight, curved or
otherwise varied. For example, the shape of the attachment
structures may be configured to follow the shape of the area of the
subject's body to which the skin treatment device is to be
attached. A tensioning device or applicator may be selected or
configured to have a profile that has a desirable profile for a
particular body location or profile where the skin treatment device
is to be placed on a subject's skin. A tensioning device or
applicator may be selected or configured to closely match a portion
of a subject's body profile. The attachment structures may be
curved, curvable, bendable, deformable, shapeable or movable to
provide alternative shapes or profiles of an attached skin
treatment device.
Attachment features or structures of a skin treatment device may
include any of the attachment structures or corresponding
structures to the attachment structures.
Attachment structures and corresponding attachment features may be
configured to provide multi direction strain or additional strain
in an orthogonal direction.
In some variations the applicator may comprise a mechanism
configured to facilitate separation, release, removal or detachment
of the attachment structures of the applicator from the attachment
features of the skin treatment device, including but not limited to
the separation devices and methods described herein. Releasing
mechanisms may include but are not limited to pivoting, rolling,
rocking or sliding features associated with or coupled to
attachment structures of the applicator. They may be self-releasing
latches or spring members. They may be actuated when a pressure
member is applied to a skin treatment device prior to removing the
applicator. They may be manually actuated. The mechanisms may
include levers, latches, locking members, spring members, for
example.
A variety of locking, latching or detent mechanisms may be used to
maintain the applicator in a various configurations including but
not limited to unstrained, partially strained, strained, unstamped,
or stamped configurations. A variety of locking, latching or detent
mechanisms may be used to maintain a skin treatment device in a
variety of configurations including unstrained, partially strained,
strained. By locking an applicator in a strained position a
predetermined strain of a given skin treatment device may be
achieved. Other locking mechanisms, including but not limited to
other locking mechanisms described herein may be used. A variable
locking mechanism may be used to vary the amount of strain for a
given skin treatment device. Such mechanisms may be releasable to
permit straining, stamping, release of the attachment structures
from the skin treatment device, or to release various structures to
permit reloading of the device.
An actuator, actuation force may be used or applied at any point
during straining of a skin treatment device and is externally
applied to the applicator, either manually or otherwise.
Optionally, an actuator or handle may be provided that provides a
mechanical advantage greater than 1 at least at some point when
actuated. Optionally a mechanical advantage may increase as a
device is strained.
Applicators configured with any of a variety of force transfer
mechanisms may be used to transfer forces exerted onto the
applicator to the skin treatment device, including but not limited
to leaf springs, helical springs, pneumatic or hydraulic struts,
sliders, helically threaded shafts, articulated linkages, pivoting
levers, and the like. The force transfer mechanisms may be
configured to transfer the resulting force onto the skin treatment
device along the same direction as the originally exerted force, or
in other configurations along a different direction. For example,
the applicator 220 in FIG. 12A transfers force along the same
direction as originally exerted by the user, while the applicator
1000 in FIG. 51A transfers the rotary force exerted by the user
into a linear spreading force, and the applicator 1100 in FIG. 53A
transfers a force that is perpendicular to the user exerted force.
Also, while some force mechanisms provide the user with a
mechanical advantage when straining a skin treatment device, e.g.
applicator 1100 in FIG. 53A, others may not, e.g. applicator 200 in
FIG. 6. These and other examples of applicators and force
mechanisms are described in greater detail below.
Applicators described herein may provide accessible areas or spaces
to access areas where the skin treatment device is applied to the
skin so that the adhesive may be pressed on to the skin. The
adhesive used may be, for example, a pressure activated adhesive
(PSA), as a silicone, acrylic, styrene block copolymer, vinyl
ether, nitrile or other PSA. In other variations, a non-pressure
sensitive adhesive may be used, including but not limited a heat or
light-cured adhesive.
In some variations, the applicator may comprise an attachment
configuration that facilitates attachment of a device to the
applicator, and a delivery configuration that stretches or strains
the attached device by about 20%, about 30%, about 40%, about 50%,
about 60%, about 70%, about 80%, about 90%, about 100%, or about
110% or more, relative to its unstretched or unstrained
configuration. The applicator may have a greater strain in the
attachment configuration than in the delivery configuration. The
applicator may be configured such that the strain it imposes
generally falls within with a one or two-sided tolerance of about
2%, about 3%, about 4%, about 5%, about 6%, about 7%, about 8%,
about 9%, about 10%, about 15%, or about 20%, for example. The load
per width imposed by the applicator onto the treatment device along
its axis of tensile strain may vary, depending upon the amount of
desired strain and the material characteristics of the device. For
example, the applicator may be configured to exert a engineering
strain of about 60% to the device using a load per millimeter width
that is in the range of about 0.1 N to about 1 N, about 0.2 N to
about 0.8 N, about 0.3 N to about 0.6 N, or sometimes in the range
of about 0.4 N to about 0.5 N or 0.6 N. In another example, the
applicator may be configured to exert a strain of about 40% to the
device using a load per millimeter width that is in the range of
about 0.05 N to about 0.6 N, about 0.1 N to about 0.5 N, about 0.2
N to about 0.4 N, or about 0.3 N to about 0.4 N. In still another
example, the applicator may be configured to exert a strain of
about 30% to the device using a load per millimeter width that is
in the range of about 0.05 N to about 0.5 N, about 0.1 N to about
0.3 N, or about 0.2 N to about 0.3 N.
The applicator may also be characterized by the force required to
compressively strain the applicator to a particular strain level,
and/or by the force the applicator exerts when the applicator is
compressed to a particular strain level. For example, the
applicator may be configured to be compressively strained to about
40% using a load per millimeter width (or dimension transverse to
the direction of strain) that may be at least about 0.1 N, about
0.2 N, about 0.3 N, about 0.4 N, about 0.5 N, about 0.6 N, about
0.7 N, or about 0.8 N or greater. In other examples, the applicator
may be configured to be compressively strain to about 20% using a
load per millimeter width (or transverse dimension) that is at
least about 0.05 N, about 0.1 N, about 0.2 N, about 0.3 N, about
0.4 N, about 0.5 N or greater. In some variations where the
material exhibits little hysteresis on it stress/strain curves, the
loading force and the unloading force at a particular level of
strain may be the same or similar.
FIGS. 3A to 4D depict one example of an applicator 100 that may be
used to generate the strain and/or maintain strain in the device
for application to a treatment site. The applicator may comprise a
resilient elastic or spring body comprising an expanded or relaxed
configuration (as shown in FIGS. 3A to 3D) and a retracted or
constrained configuration (as shown in FIGS. 4A to 4D). The
applicator 100 may comprise an elastic body 102 with first and
second device attachment structures 104 and 106 that are configured
to releasably engage the applicator attachment structure 40 and 42
of the treatment device 2 illustrated in FIGS. 1A to 2B. Here, the
attachment structures 104 and 106 comprise a plurality of
projections 108 and 110 that may be inserted into the openings 44
and 46 of the devices. The projections may have any of a variety of
shapes, orientations, sizes or thicknesses. In this particular
variation, the projections 108 and 110 are angled upwards from the
base structures 112 and 114 of the applicator 100 (e.g. away from
an attached device). The angle may be anywhere in the range of
about 0 degrees to about 90 degrees or more, in some variations
about 15 degrees to about 75 degrees, and in other variations about
25 degrees to about 45 degrees. The angles of the projections 108
and 110 may be uniform or non-uniform between the two sets or
between individual projections. The shape of the projections may be
square, rectangular, triangular, bulbous, mushroom-like, or the
like. In some variations, the transverse dimension of the
projections may be greater than the corresponding transverse
dimension of the openings 44 and 46 of the treatment device 2,
which may result in stretching or deformation of the openings 44
and 46 when attached to the applicator 100. The resistance from the
deformation of the openings 44 and 46 may reduce the rate of
inadvertent detachment of the treatment device 2 from the
applicator 100. In variations comprising a mushroom or bulbous
configuration, the rounded distal end of the projection may reduce
the risk of damaging the device during loading, while the increased
transverse dimension of the projection distally and the reduced
transverse dimension of the projection proximally may provide
tactile feedback to the user during loading that may indicate
proper loading, and may also reduce the risk of device damage by
reducing stretching of the openings once loaded. The projections
may have a length of about 500 microns to about 5 mm or more, in
some variations about 1 mm to about 4 mm, and in other variations
about 2 mm to about 3 mm. The thickness of the projections may be
the same, lower or greater than the elastic body 102 of the
applicator 100. The elastic body 102 may comprise any of a variety
of elastic materials, including but not limited to polymeric and
metallic materials. In other variations, generally malleable
polymeric or metallic materials may be used.
To facilitate the application of pressure against the device 2 and
onto the skin, the base structures 112 and 114 may further comprise
pressure pads 116 and 118 or other padded/deformable structures
that may conform to the contours of the skin surface, which may
redistribute forces exerted onto the treatment device 2 through the
applicator 100 across the surfaces of the pads 116 and 118. The
pressure pads 116 and 118 may comprise any of a variety of
deformable materials, including foams (open and closed cells),
gels, and the like.
In some variations, the device may comprise further indicia that
may be used to indicate proper loading and/or straining of the
device. In FIGS. 1A and 2A, for example, the geometry of lines 74
and 76 may be remain generally linear when all of the openings 40
and 42 of the treatment device 2 are engaged by the projections 108
and 110, but may be deformed or become non-linear if one or more of
the openings 40 and 42 are missed, due to variations in the degree
of stretching across the treatment device 2. The lines 74 and 76
may also align with corresponding indicia on the applicator 100
(e.g. the base structures 112 and 114 and/or the pressure pads 116
and 118) to indicate proper loading and/or stretching of the
treatment device 2.
In some variations, the applicators may be manually maintained in a
retracted state by the user during loading by squeezing or
otherwise exerting compressive forces onto the applicator. In other
variations, as shown in FIGS. 3A to 4D, the applicator 100 may
comprise a locking mechanism 120 that may be used to maintain the
applicator 100 in one or more configurations. In this particular
variation, the locking mechanism 120 comprises a latch 122 that
releasably engages a tab 124 located in an opening 126 or recess of
the elastic body 102. The latch 122 may be biased against the tab
124 such that as the tab 124 slides along the length of the latch
122 as the elastic body 102 is compressed, until the tab 124
engages a tab opening 134 (depicted in FIGS. 4A, 4C and 4D) on the
latch 122 and locks in the compressed configuration of the elastic
body 102. To resist complete disengagement between the latch 122
and the opening 126 in the elastic body 102, the opening 126 may
comprise a retention bar 128 that the distal section 130 of the
latch 122 may be wrapped around. The latch 122 may be attached to
the elastic body 102 by a rivet 132, or by welding or gluing, for
example. In other examples, the latch may be integrally formed by
laser cutting or punching out the latch structure from the elastic
body. In some variations, the applicator may be configured with two
or more latches.
In other variations, the latch may not be biased against the tab
and may be manually engaged the user at the desired locking
position. In other variations, the latch may have a plurality of
tab openings to permit locking into a variety of configurations. In
still other variations, the latch may comprise a projection or tab
that engages an opening or recess of the elastic body. In alternate
variations, the locking mechanism may comprise a ratchet mechanism,
locking pin mechanism, or resistance screw, for example.
FIGS. 3A to 3D depict the applicator 100 in its base configuration
with reduced strain, if any. To facilitate loading of the treatment
device 2, the applicator 100 may be compressed, until the
applicator 100 is locked into a compressed configuration, as
illustrated in FIGS. 4A to 4D, which may reduce the degree of
stretching, if any, needed to load the device onto the applicator
100, as depicted in FIGS. 5A and 5B. Once the device is loaded, the
locking mechanism 120 may be disengaged by pressing the latch 122
away from the locking tab 124. The potential energy in the elastic
body 102 from its compression is then released to permit stretching
of the attached treatment device 2 and is ready for adhesion to the
skin. As shown, the elastic body 102 comprises a sheet of
semi-rigid material, but in other variations, may have a frame-like
configuration. In some variations, the elastic body may comprise
stainless steel with a thickness in the range of about 500 microns
to about 3 mm or more, in some variations about 1 mm to about 2 mm,
and in other variations about 1 mm to about 1.5 mm. The elastic
body 102 may be configured with as a number of angled panel
regions, as depicted in FIGS. 3A to 4D, with generally horizontal
base structures 112 and 114 that may be generally orthogonal to
side panels 140 and 142, which in turn form an angle of about 135
degrees each (as measured from the inferior surface of the elastic
body 102) with the central panels 144 and 146 which in turn may be
generally oriented at about a 90 degree angle with each other. The
angles between the panels may be sharp angles or rounded angles,
and may be configured differently depending upon the particular
skin site (e.g. limb vs. torso), or degree of desired strain (e.g.
a more obtuse angle between the central panels 144 and 146). In
other variations, the angle between any two panels or base
structure may be in the range of about 0 to about 360 degrees, in
some variations about 45 to about 135 degrees, and in other
variations about 75 to about 90 degrees (as measured from the
underside or topside of the elastic body 102). The latch mechanism
120 may be attached or involve the central panels as shown in FIGS.
3A to 4D, but in other variations may be attached or involve the
side panels or base structures. In other variations, the elastic
body may comprise a curved structure, including but not limited to
an omega-shaped structure. As illustrated in FIGS. 3A to 5B, the
non-planar configuration of the applicator 100 provides an open
region 150 between the pressure pads 116 and 118 and side panels
140 and 142, which permits access to the superior surface of an
attached device to facilitate positioning of the device to a
treatment site and/or to permit direct access or the application of
pressure to the central portion of a device by the user (e.g. using
fingers or other instrument). As shown in FIGS. 5A and 5B, the
treatment device 2 and the applicator 100 may be configured so that
the inner adhesive regions 20 and 22 are generally located
underneath the pressure pads 20 and 22 when the treatment device 2
is loaded onto the applicator 100.
In other variations, the applicators usable with the wound
treatment device may not be configured to actively exert force onto
the device, and/or need not have a generally angled or curved
design. In FIG. 6, for example, the applicator 200 has a generally
planar configuration and comprises two device attachment structures
202 and 204 that are connected by strut or frame members 206 and
208 that are configured to slide or move with respect to at least
one of the device attachment structures 204, if not both. In FIG.
6, for example, the strut or frame members 206 and 208 may be
fixedly mounted to one of the attachment structure 202, but are
slidably mounted to the other attachment structure 206 by clamps
210 and 212. The clamps 210 and 212 depicted in FIG. 6 are friction
clamps that may be pinched or compressed to at least partially
release or relieve the frictional resistance between the frame
members 206 and 208 and the clamps 210 and 212, which permits
separation or contraction of the applicator 200. The attachment
structures 206 and 208 may further comprise tabs 214 and 216 or
handles to facilitate manipulation and/or positioning of the
applicator 220. In use, the user will attach a device 2 to the
applicator 200, and then manually stretch the device 2 by pulling
apart the clamps 210 and 212. To use this applicator 200, the
attachment structure 204 is slid toward the other attachment
structure 202 along frame members 206 and 208 until the spacing
between the attachments structures 202 and 204 is sufficiently
reduced to facilitate attachment of a complementary treatment
device (not shown) without requiring significant stretching, if at
all. Once attached, the attachment structure 204 is pushed or
pulled away from the other attachment structure 202 until the
desired degree of stress or strain in the treatment device is
achieved. The treatment device is then applied to the treatment
site, and then the attachment structure 204 is slid along the frame
members 206 and 208 again to relieve the stress and strain in the
treatment device and to permit separation of the applicator 200
from the treatment device.
In the particular variation depicted in FIG. 6, the applicator 200
comprises two frame members 206 and 208 located on the periphery of
the applicator 220 to provide a central access region 218 that may
facilitate positioning of the attached device or to direct access
to the device. In other variations, the applicator may comprise a
single frame member or three or more frame members, and the
applicator may comprise one or more frame members that are
centrally located or otherwise spaced away from the periphery of
the applicator. In other variations, other types of movable or
lockable mechanical interfaces may be provided between the frame
members and the attachment structures, including but not limited to
locking pins, thumbscrews, and the like. In another variation,
helical springs may be provided along the frame members to 206 and
208 to bias or exert a separation force between the attachment
members 202 and 204. In still other variations, such as the
applicator 220 depicted in FIG. 12A, force members 222 and 224,
which may be coil or pneumatic struts, for example, may also be
used.
FIGS. 11A and 11B depict another variation of an applicator 320
comprising bendable or deformable frame members 322 that may or may
not be biased to a configuration that exerts a stretching force on
an attached device. In this particular variation, the bendable
frame members 322 comprise a frame member 322 with a hinge 324, but
in other variations, other mechanical joints, or a malleable or
other deformable frame member may be used. The applicator 320 may
be bent or angled to facilitate loading of a device onto its
attachment structure 326. Once attached, the device may be strained
by straightening the configuration of the frame member 322, as
shown in FIG. 11B. The frame member 322 may be maintained in the
straight configuration using a locking sleeve 328 that is
positioned over the hinge joint to restrict motion. The sleeve 328
may be configured to slide and/or rotate in and out of locking
position, and may or may not reduce the risk of inadvertent
unlocking.
The length of the attachment structures of the applicator may vary,
and as depicted in FIG. 7, the applicator 240 may comprise two or
more elastic bodies 242 and 244, each of which may have a locking
mechanism 246 and 248, and a central access region 250 between the
elastic bodies 242 and 244, which may facilitate device placement
by permitting visualization of the treatment site. In other
variations, such as the applicator 220 in FIGS. 12A and 12B, the
force members 222 and 224 may be separately coupled to the
attachment members 226 and 228 from the locking mechanism 230, e.g.
the locking mechanism may be attached to the attachment members 226
and 228 rather than the force members 222 and 224. In FIG. 12A, the
locking mechanism 230 comprises complementary ratchet/toothed
members 232 and 234 that engage once the applicator 220 is
sufficiently squeezed or retracted. In contrast to the locking
mechanism 120 described in FIGS. 3A to 5B, the locking mechanism
230 in FIG. 12A is able to lock the applicator configuration across
a range according to the degree of overlap or engagement between
the ratchet/toothed members 232 and 234. To release or separate the
locking mechanism 230, a tab, handle, or ring 236 may be provided
on one or both ratchet members 232 and 234 to facilitate
disengagement.
As illustrated in FIGS. 8 and 9, to facilitate conforming a wound
treatment device to a treatment site, the applicators 260 and 280
may be configured with attachment structures 262 and 282,
respectively, that are able to bend or deform along their
longitudinal lengths. In FIG. 8, for example, the attachment
structures 262 comprise hinge mechanisms 264 that permit bending at
one or more locations. The hinges 264 may or may not be configured
to limit the degree or range of bending. In FIG. 9, the applicator
280 comprises attachment structures 282 with segments 284, 286 and
288 that are attached by bendable or deformable wires 290 or
struts. In this particular variation, each wire 290 spans all three
segments 284, 286 and 288, but in other variations, one or more
wires may be configured to span two or less than all of the
segments.
In some variations, the attachment structures of the applicator may
or may not comprise discrete segments but may comprise a material
or configuration that permits flexion along their longitudinal
length. In still other variations, the attachment structures may
have non-linear or non-planar configurations. In FIG. 10, for
example, the applicator 300 comprises an attachment structure 302
with a fixed curvature or curvilinear configuration. In still other
examples, the applicator may have a curved or curvilinear base
configuration, but may elastically deform in one or more
directions. The degree of curvature may vary and may or may not
comprise an arc of a circle or oval structure. The curved
attachment structures may be used with applicators 300 comprising
frame members 304, for example, or with applicators with comprising
sheet or leaf spring members, for example.
In one variation, to use the wound treatment system, the patient
may be positioned so that the incision site is in a non-stressed,
tension free position. For an abdominoplasty incision site, for
example, the patient may be standing up or lying in supine
position, and for a breast incision site, the patient may be lying
in the supine position. The incision site may then be cleaned with
an agent alcohol or other cleaning agent. In some further
variations, a separate skin adhesive or adjunctive agent (e.g.
tincture of benzoin) may be applied adjacent to the incision site
prior to the application of a bandage.
An applicator may be manipulated into a retracted position and then
locked to that position. In some variations, the locking occurs
automatically, while in other variations, the locking is manually
actuated. Referring to FIGS. 13A to 13D, and using the treatment
device 2 in FIG. 1A and the applicator (not shown), for example,
the applicator may be squeezed or compressed until the latch
automatically snaps into position. A treatment device 2 is oriented
with the adhesive surface (or release liner 56) facing away from
the applicator and then attached to the device attachment
structures of the applicator, e.g. by inserting the attachment
projections and through the retention openings 44 and 46 of the
treatment device 2. In some variations, some stretching of the
device may occur as the device is attached to the applicator, and
in some instances, the release liner of at least the inner adhesive
regions 20 and 22 may be removed to facilitate the stretching. This
may be performed between the engagement of the two sets of openings
44 and 46 of the treatment device 2, for example, or after the
attachment of the treatment device 2 to the applicator is
completed. Once the attachment of the treatment device 2 has been
confirmed, the applicator may be released from the locked position,
e.g. by actuating the latch to strain the device, as depicted in
FIG. 13B. In some variations, markings or indicia on the treatment
device 2 (e.g. lines 74 and 76 of the treatment device 2 in FIG.
2A) may be used to assess proper attachment of the device to the
applicator. In some examples, the applicator may be squeezed to
facilitate unlatching. Once unlocked, the applicator exerts a
separation force that pushes apart the attachment sites of the
device to a pre-determined strained configuration.
To apply the device 2, the device 2 may be oriented by identifying
the central non-adhesive region 18 of the treatment device 2 and
aligning this region with a wound or incision site 90. Pressure is
applied to the applicator to secure the treatment device 2 to the
site 90. In some variations, the foam structures (or other pad
structures) of the applicator are compressed or otherwise deformed
as the applicator is pushed against the skin. In some examples, the
user may also apply manual pressure directly to the device and
against the skin by inserting his or her fingers between the device
attachment sites of the applicator. The site 90 may or may not
already be closed using sutures 92 or other wound closure devices,
e.g. staples, glues, and the like. In variations, the site 90 may
be closed with subcutaneous sutures but not cutaneous sutures.
Once the treatment device 2 is secured to the site 90, the
applicator may be disengaged from the device by squeezing the
applicator. In some variations, one device attachment site of the
applicator may be held in place (e.g. the "thumb" side of the
applicator as it is held by the user) while the other device
attachment site is released from the retention apertures of the
device (e.g. displacing the "finger" side of the applicator toward
the "thumb" side of the applicator). Once one side of the device is
released, the applicator may be detached from the other side of the
device, e.g. by withdrawing the attachment projections of the
applicator from the remaining retention apertures. In examples
where multiple devices are placed, the above steps may be repeated
until the entire incision site is covered. In some variations, the
multiple devices are placed edge-to-edge with adjacent devices
while reducing any overlap or gaps between the devices. The release
liner of the end flaps may be removed and the end flaps 48 and 50
may be secured to the skin using finger pressure. The end flaps may
or may not be stretched or tensioned by the user before being
pressed against the skin.
FIGS. 50A to 50F illustrate one variation of a tensioning device,
straining device or applicator 900. The applicator 900 comprises an
actuator or handle 901 having a first handle member 902 with pivot
arm 904 and a second handle member 903 with second pivot arm 905.
Attachment structures 906, 907 are respectively coupled to distal
portions of pivot arms 904, 905. Attachment structures 906, 907
each comprise an elongate portion 908 having one or more tabs or
extensions 909 extending from the elongate portion 908. The
extensions 909 may be used to attached to a skin treatment device
such as, for example, as described with respect to the skin
treatment device 2010 and attachment device 2003 illustrated in
FIGS. 64A and 64B herein. Alternative attachment structures may be
used as discussed in further detail herein.
The handle members 902, 903 are pivotally coupled by connector 910
at the pivot arms 904, 905 to provide a pivot point or fulcrum, to
transfer force from the handle 901 of applicator 900 to a skin
treatment device when coupled to the attachment structures 906,
907, to thereby strain the skin treatment device prior to placement
on skin.
FIG. 50A illustrates an actuator or handle configuration prior to
straining a skin treatment device for application to the skin of a
subject. A skin treatment device may be attached to the attachment
structures 906, 907. When an external force is applied to the
actuator, e.g., the handle members 902, 903 of the handle 901 are
squeezed together, the force is transferred to provide a separation
force between the attachment structures 906, 907 coupled
respectively to pivot arms 904, 905. Optionally, the handle may be
provided with a distance d2 from the top 911 to the fulcrum or
pivot point 912 that is greater than the distance d1 from the pivot
point 912 to an attachment structure 906 or 907. Thus, the actuator
or handle may provide a mechanical advantage greater than 1 when
actuated. In some variations, d2 may be greater than d1 by at least
about 10%, about 20% about 30%, about 40%, about 50% about 76% or
about 100% or more. In other examples, d2 may be measured from the
midpoint of the handle, rather than the top of the handle.
FIG. 50B illustrates the applicator 900 in a strained
configuration. For purposes of clarity, an attached skin treatment
device is not shown, but the pocketed skin treatment devices
illustrated in FIGS. 43A to 43C, for example, may be adapted for
use with applicator 900. The handle members 902, 903 have been
squeezed together and a separation force has been exerted between
the attachment structures 906, 907 to strain an attached skin
treatment device 930 (shown in FIG. 50F). The applicator 900 may or
may not have a mechanism to lock to maintain the skin treatment
device in a strained configuration. In the variation depicted in
FIGS. 50A to 50F, the handle members 902, 903 are lockable together
by a locking mechanism 915 that may be locked to prevent or resist
separation of the handle members 902, 903 and unlocked to release
the strain exerted on the skin treatment device. FIG. 50C depicts
the locking mechanism 915 is prior to closure of the handle members
902, 903, and FIG. 50D depicts it after closure of the handle
members 902, 903.
Referring to FIGS. 50C and 50D, the locking mechanism 915 comprises
a spring loaded catch 916 in handle member 902 that is depressed by
cammed surface 920 of cavity in handle member 903, as the handle
members 902, 903 close. The catch 916 may be biased upward into
notch 917 after handle members 902, 903 close. The catch 916 may be
released from engagement in notch 917 by depressing release member
918 to compress spring 919 and separating handle members 902, 903.
Thus the attachment structures 906, 907 may be released from an
attached skin treatment device after application to the skin. By
locking the applicator in a strained position a predetermined
strain of a given skin treatment device may be achieved. Other
locking mechanisms, including but not limited to other locking
mechanisms described herein may be used. A variable locking
mechanism may be used to vary the amount of strain for a given skin
treatment device.
The attachment structure profile may be straight, curved or
otherwise varied. For example, the shape of the attachment
structures may be configured to follow the shape of the area of the
subject's body to which the skin treatment device is to be
attached. In accordance with another variation the applicator 900
is illustrated with curved or curvable attachment structures 906,
907. As shown in FIG. 50E torsion springs 922, 923 are respectively
coupled to pivot arms 904, 905. Torsion spring arms 924, 925 (with
spring tips 924a, 925a to apply a downward force) extend along
elongated portions 908 of attachment structures 906, 907
respectively. The biases of the spring arms 924, 925 and tips 924a,
925a, apply a downward force to cause the attachment structures
906, 907 to bend to form a curved skin treatment device 930. As
shown in FIG. 50F, a curved or shaped skin treatment device 930 may
be applied to a curved or shaped surface 928 of a subject's skin.
The amount of torsion in the springs 922, 923 may be varied to
provide a varying degree of curvature. A tensioning device or
applicator may be selected or configured to have a profile that has
a desirable profile for a particular body location or profile where
the skin treatment device is to be placed on a subject's skin. A
tensioning device or applicator may be selected or configured to
closely match a portion of a subject's body profile, as shown in
FIG. 50F, where a concavely shaped side of the skin treatment
device generally matches the convex shape of the subject's body
profile where the device is to be attached. The attachment
structures may be curved, curvable, bendable, deformable, shapeable
or movable to provide alternative shapes or profiles of an attached
skin treatment device.
To remove the handle 901 from the skin treatment device, the
release member 918 may be actuated so that the handle members 902,
903 may be separated, thereby separating the attachment structures
from the attachment features of the skin treatment device. A
variety of methods and devices may be used to provide for an easy
separation of the attachment structures of an applicator from the
attachment features of the skin treatment device including but not
limited to the separation devices and methods described herein.
FIGS. 51A to 51D illustrate another variation of a tensioning
device, straining device, or applicator 1000. Here, the applicator
1000 comprises an actuator or handle 1001 having a screw handle
1002 and threaded post 1003. The screw handle 1002 comprises a
complementarily threaded lumen that may be rotated to advance it up
or down the threaded post 1003. A stop 1005 at the top of threaded
post 1003 may be provided to resist or prevent the screw handle
1002 from advancing beyond the top of the threaded post 1003. A
sliding collar 1004 is positioned on the post 1003 below the screw
handle 1002. Lever arms 1010, 1011 have first end portions 1012,
1013 respectively that are pivotally coupled to the sliding collar
1004 at pivot points 1020, 1021. Second or opposite end portions
1014, 1015 are pivotally coupled to attachment structures 1006,
1007 by way of attachment bars 1016, 1017 at pivot points 1022,
1023 respectively. Attachment bars 1016, 1017 are also pivotally
attached to the bottom of the post 1003 at pivot points 1024,
1025.
Attachment structures 1006, 1007 may be respectively coupled to
distal portions 1014, 1015 of pivot arms 1010, 1011. Attachment
structures 1006, 1007 each comprise an elongate portion 1008 having
one or more tabs or extensions 1009 extending from the elongate
portion 1008. The extensions 1009 may be used to attached to a skin
treatment device such as, for example, as described with respect to
the skin treatment device 2010 and attachment device 2003
illustrated in FIGS. 64A and 64B herein. Alternative attachment
structures, and corresponding attachment configurations on the skin
treatment devices that may be used are discussed in further detail
herein. The attachment structure profile may be straight, curved or
otherwise varied. For example, the shape of the attachment
structures may be configured to follow the shape of the area of the
subject's body to which the skin treatment device is to be
attached, may be curved, curvable, bendable, deformable, shapeable
or movable to permit various skin treatment device shapes to be
formed including but not limited to, as shown in FIG. 50F
herein.
FIGS. 51A and 51C depicts the applicator 1000 in an unstrained
position, with the screw handle 1002 is in a relative position
advanced downward from the stop 1005 of the post 1003. The
attachment structures 1006, 1007 are pivoted or angled in with
respect to each other and are in a closed position where the
distance between them is smaller than when strained. This position
facilitates loading or release of a skin treatment device from the
applicator.
As shown in FIGS. 51B and 51D, when the screw handle 1002 is
rotated to advance the post 1003 inferiorly, the post 1003 pushes
relatively downward on attachment bars 1016, 1017 at pivot points
1024, 1025 while lever arms 1010, 1011 move relatively upward with
collar 1004, thereby pulling up on attachment bars 1016, 1017 at
pivot points 1022, 1023 and applying forces that separate and
outwardly rotate the attachment structures 1006, 1007 into a
flatter more planar configuration with respect to each other. As
the screw handle 1002 is rotated moving the device from an
unstrained towards a more strained configuration, the structures of
the handle 1001 hold the attachment structures 1006, 1007 in
position. Thus the handle 1001 holds or locks the applicator 1000
in its relative strained position. Various positions of the screw
handle 1002 on the post 1003 may correspond to various degrees of
strain of a particular skin treatment device. Markings may also be
made on the post to identify a relative strain of a skin treatment
device with respect to screw handle 1002 positions.
To remove the handle 1002 from the skin treatment device, the screw
handle 1002 may be rotated in an opposite direction so that the
attachment structures move inward and rotate to separate them from
the attachment features of the skin treatment device. The number of
handle turns to move applicator 1000 from an unstrained to strain
position, and vice versa, may vary from about a half-turn to about
1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or more turns, depending upon the
pitch of the threading. The pitch of the helical threading (i.e.
the width of one complete turn) may be selected depending upon the
desired mechanical advantage and/or self-locking effect, e.g.
resisting rotation that may occur from an attached skin treatment
device squeezing attachment bars 1016, 1017. Typically, smaller
pitches may be used to increase the mechanical advantage or
self-locking feature, but may be more tedious to manipulate.
FIGS. 52A to 52H, illustrate another variation of a tensioning
device, straining device, or applicator 1030, comprising an
actuator or handle 1031 having a body 1033 with a cam handle 1032
and locking tabs 1050. The cam handle 1032 may be rotatably
positioned on top of the body 1033 and attached to a cam 1055 which
is positioned under the body 1033. At least one of parallel u-bars
1040, 1041 is slidably mounted on at least one of posts 1034, 1035,
which are attached to the handle body 1033 with mounts 1045. As
shown, in FIGS. 52A and 52C, post 1034 extends through and can
slide through opening 1048 in u-bar 1040. Post 1035 extends through
and can slide through opening 1049 in the u-bar 1041. U-bars 1040,
1041 further comprise inner surfaces 1042, 1043 that interact with
cam surfaces 1052, 1053 or cam 1055.
The bars 1040, 1041 couple skin treatment device attachment
structures 1036, 1037 to body 1033 of the applicator 1030.
Attachment structures 1036, 1037 are coupled to struts or legs
1058, 1059 of u-bars 1040, 1041. In other variations, rather than a
u-shaped bar, a single strut or a group of three or more joined
struts may be provided, and the struts may or may not be parallel
relative to one another, or perpendicular to the body of the
applicator 1030, e.g. the struts may be acutely or obtusely angled.
As illustrated in FIG. 52A, attachment structures 1036, 1037 each
comprise an elongate portion 1038 having one or more tabs or
extensions 1039 extending from the elongate portion 1038. The
extensions 1039 may be used to attach to a skin treatment device
such as, for example, as described with respect to the skin
treatment device 2010 and attachment device 2003 illustrated in
FIGS. 64A and 64B herein. Alternative attachment structures may be
used as discussed in further detail herein. The attachment
structure profile may be straight, curved or otherwise varied. For
example, the shape of the attachment structures may be configured
to follow the shape of the area of the subject's body to which the
skin treatment device is to be attached, may be curved, curvable,
bendable, deformable, shapeable or movable to permit various skin
treatment device shapes to be formed including but not limited to,
as shown in FIG. 50F herein.
FIGS. 52A, 52C, 52E and 52G show the applicator 1030 in an
unstrained position. The u-bars 1040, 1041 are in relatively close
parallel position with respect to each other. Thus the attachment
structures 1036, 1037, coupled to the bars are relatively close
with respect to each other to facilitate the loading of an
unstrained skin treatment device on to the attachment structures
1036, 1037.
As shown in FIGS. 52B and 52D, the cam handle 1032 is rotated, the
cam surfaces 1052, 1053 interact with the inner surfaces 1042, 1043
of the bars 1040, 1041 to apply a separating force between the
u-bars 1040, 1041 and thus to attachment structures 1036, 1037 to
thereby strain an attached skin treatment device (not shown). The
skin treatment devices illustrated in FIGS. 43A to 43C may be
adapted for use with applicator 1030. As the cam handle 1032 is
rotated about point 1051 using an external force, the cam 1055
moves the device from an unstrained towards a more strained
configuration where bars 1040, 1041 are in a more separated,
generally parallel position with respect to each other. The locking
tabs 1050 may be depressed to lock the applicator 1030 in its
relative strained position, i.e. to maintain the strain of the skin
treatment device. The locking tabs 1050 when moved to the locking
position as shown in FIG. 52H interfere with movement u-bars 1040,
1041 by engaging inner walls 1042, 1043. When the applicator 1030
is in an unstrained position, the locking tabs extend above housing
1033 (as depicted in FIG. 52G).
To remove the handle 1031 from the skin treatment device, the
locking tab 1050 is released to the position illustrated in FIG.
52G so that the cam handle 1032 may be rotated in an opposite
direction. This moves the attachment structures 1036, 1037 closer
together and permits the attachment structure 1036, 1037 to
separate from the attachment features, e.g., pockets or hook or
loop structures, of the skin treatment device.
FIGS. 53A to 53E depicts another variation of a tensioning device,
straining device, or applicator 1100, comprising a handle 1101 or
actuator configured to be actuated to strain a skin treatment
device and/or to apply the device to the skin of a subject. The
applicator 1100 includes attachment structures 1106, 1107. In the
variation illustrated in FIGS. 53A to 53E, the attachment
structures comprise spring loaded binder type clips that grasp or
pinch ends of a skin treatment device or an attachment structure on
ends of the skin treatment device, but the applicator or skin
treatment device attachment structures may comprise other types of
attachment structures or features, including but not limited to
other attachment structures and features set forth herein.
The applicator 1100 may further comprise a moveable, slidable or a
collapsing or expanding top frame structure 1102, opposing
stationary walls 1108, 1109 and opposing movable, pivotable or
hinged walls 1110, 1111. Frame structure 1102 comprises a pair of
slidable elements 1120, 1121 and pair of slidable elements 1122,
1123. Each of the pair of slidable elements 1120, 1121 and 1122,
1123 can slide together into a closed position (FIGS. 53A and 53C)
where there is a first distance d1 (depicted in FIG. 53C) between
walls 1108 and 1109. The pairs of slidable element 1120, 1121 and
1122, 1123 can slide apart into a second open position where there
is a second distance d2 (depicted best in FIG. 53D) between the
walls 1108, 1109 and where the distance d2 is greater than the
distance d1.
Hinged wall 1110 comprises a first and second wall portions or
segments 1112a, 1113a that are movably, pivotally or hingedly
connected to each other by connector 1114a, at a pivot point.
Hinged wall 1111 comprises a first and second wall segments 1112b,
1113b that are movably, pivotally or hingedly connected to each
other by connector 1114b at a pivot point. Wall segments 1112a and
1113b are movably, pivotally or hingedly coupled respectively to
opposite end sides 1108a, 1108b of wall 1108. Wall segments 1112b
and 1113a are movably, pivotally or hingedly coupled respectively
to opposite end sides 1109b, 1109a of wall 1109. The walls 1108,
1109, 1110, 1111 are coupled to the frame structure 1102 to form a
box-like structure with an opening (when in the strained
configuration) to provide access to a skin treatment device
attached across the bottom of the applicator to attachment
structures 1106, 1107. The access allows a user to apply pressure
to a skin treatment device as or after it is applied to a skin
surface before removing the applicator 1100. Alternatively, a
pressure application device may be coupled to the applicator and
actuable to provide pressure through the opening to a skin
treatment device as or after it is being applied.
FIGS. 53A and 53C illustrate the applicator 1100 in a first,
unstrained position. The frame structure 1102 is in a collapsed
position where slidable supports or elements 1120, 1121 and
slidable elements 1122, 1123 are in a folded closed position. In
this position, subsupports or wall segments 1112a and 1113a are
pivoted to form a v-shape extending outward of the applicator, and
wall segments 1112b and 1113b are pivoted to form a v-shape
extending outward of the applicator 1100 so that the distance
between end walls is a distance d1. This configuration may
facilitate loading of an unstrained skin treatment device. After an
unstrained device is loaded, the skin treatment device is strained
by applying pressure to the v-shaped walls 1110, 1111 (for example
by manually squeezing the v-shaped or collapsed walls shown in
FIGS. 53A and 53C). This action forces the pairs of sliding
elements 1120, 1121 and 1122, 1123 into a spread, elongated or open
position, as shown in FIGS. 53B, 53D and 53E. In the spread or open
position, the frame structure 1102 transferring a separation force
from the wall segments 1112a and 1113a to the skin treatment device
to strain the skin treatment device along a strain axis. When the
applicator 1100 is in the strained position, as shown in FIG. 53E,
the wall segments 1112a, 1113a and 1112b, 1113b of walls 1110 and
1111 may be configured to pivot slightly inward and/or off-center
to lock the applicator 1100 into place or to resist collapse of the
walls back into the v-shaped configuration. Thus, the applicator
1100 and an attached strained skin treatment device may be
configured to maintain or lock in a strained configuration without
continuous user applied force.
Grasping members 1105 may be provide to facilitate grasping of the
device when applying a skin treatment device to the skin of a
subject. Although each of the grasping member 1105 are depicted to
opposite sides of their respective pivot connectors 1114b, in other
example, the grasping members may be located on the same sides of
their respective pivot connectors, or lie across or on both sides
of the pivot connectors.
In some variations, the use of two opposing and collapsible walls
to separate to slidable walls of a fixed configuration, as
illustrated in the applicator 1100 depicted in FIGS. 53A to 53E, as
wells similar applicators such as those illustrated in FIGS. 54A to
54I, FIGS. 56A to 57I, for example, may provide a mechanical
advantage when applying a strain to a skin treatment device. A
mechanical advantage may be characterized by an output force that
is greater than the input force, and may be described as a ratio of
the output force divided by the input force that is greater than 1.
In some variations, the mechanical advantage may be at least about
1.1, about 1.2, about 1.3, about 1.4, about 1.5 about 1.7, or about
2 or more. The mechanical advantage may or may not be provided
throughout the entire movement range of the applicator.
Referring to FIG. 54J, the mechanical advantage of the collapsing
box, with two opposing slidable walls having a fixed configuration
separated by initial distance d2 and two collapsible opposing
walls, each comprising two wall segments of length d1 and forming
an angle .alpha. between a wall segment and an intersecting midline
may be calculated as: F.sub.x=F.sub.y/Tan .alpha.
The width of the slidable walls d3 permits skin treatment devices
of up to a comparable width d3, which may affect the absolute level
of force necessary to strain the attached skin treatment device,
but may not direct impact the mechanical advantage provided by the
collapsing box design. It is noted from the above equation that
where angle .alpha. is initially 45 degrees at a 0% strain, a
mechanical advantage is provided along the entire strain process.
Thus, in some variations, the applicator may be configured to have
an initial angle .alpha. of about 45 degrees, but in other
examples, the initial angle .alpha. may be in the range from about
1 degree to about 90 degrees, sometimes about 15 degrees to about
75 degrees, and other times about 30 degrees to about 60 degrees,
and still other times about 30 degrees to about 45 degrees.
However, use of an initial angle .alpha. that is less than about 45
degrees at 0% strain may permit a greater degree of straining,
compared to designs with an initial angle .alpha. of about 45
degrees or more. In some designs where an initial angle .alpha. of
less than about 45 degrees is used, although no initial mechanical
advantage, the absolute level of force to be exerted by the user to
generate the initial, smaller strains (e.g. up to about 10% or
about 20% strain) in the skin treatment device may not be
significant compared to the absolute greater strains needed for
higher levels of strain (e.g. about 40% or about 60% strain).
FIG. 54K is a table that lists the resulting load based upon a
collapsing box applicator design attached to a 6 cm dressing, where
the collapsible walls are configured with an angle .alpha. of about
45 degrees at a strain of o %. As depicted in the graph of FIG.
54L, the plot of the force exerted by the user at each level of
strain (10%, 20%, 30% and 40%) is generally at or below the level
of force generated by the applicator. In this particular
configuration, the user input force gradually increases from about
0% to about 20%, then plateau to about 30%, and then decreases
toward zero at a strain of about 40%.
FIG. 54M is a table that lists the resulting load for a collapsing
box applicator design attached to a 6 cm dressing, where the
collapsible walls are configured with an angle .alpha. of about 40
degrees at a strain of 0%, and also where strains up to 60% were
measured. As shown in the graph of FIG. 54N, the plot of the force
exerted by the user at each level of strain (10%, 20%, 30%, 40%,
50% and 60%) at or slightly above the output force until angle
.alpha. is about 45 degrees (approximately 12% strain) but is at or
below the level of force generated by the applicator for greater
strains (e.g. about 20% to about 60%).
FIG. 54O is a table that lists the user input force required to
maintain a constant output force (here normalized to 1 Lbf) from a
strain of 0% to 60%. As shown in the graph of FIG. 54P, to generate
a constant force across for strain up to 40%, the required user
input force is initially greater until angle .alpha. is about 45
degrees (approximately 12% strain), then gradually decreases (at a
generally constant slope) as the level of strain increases (up to a
strain of 40% is depicted in FIG. 54P).
Other examples of applicator designs that may be configured with a
mechanical advantage are described elsewhere herein.
FIGS. 54A to 54D illustrate another variation of a tensioning
device, straining device or an applicator 1200. The applicator 1200
comprises a handle 1201 or actuator configured to be actuated to
strain a skin treatment device 1240 and/or to apply the device to
the skin of a subject. The applicator 1200 includes end attachment
structures 1206, 1207. In some variations, the applicator may also
include side attachment structures 1203, 1204, 1220, 1222 that may
interface with structures 1203 and 1204 be attached to the sides of
a skin treatment device. This interface may provide a second
dimension or axis to the tension or strain applied to the skin
treatment device. Thus the skin treatment device may be strained in
orthogonal directions or at least two directions, i.e., the
applicator provides a bi-directionally or multi-directionally
strained skin treatment device. The attachment structures may be
located on the bottom of bump features 1245 on wall segments 1220,
1222. The attachment structures 1206, 1207 may comprise engagement
flaps having edges that engage attachment features 1246, 1247 of a
corresponding skin treatment device 1240. Attachment structures
1203, 1204 as shown are hook or loop structures that have
corresponding hook or loop structure attachment features on the
back side of the skin treatment device. The applicator or skin
treatment device attachment structures may comprise other types of
attachment structures, including but not limited to other
attachment structures described or set forth herein.
The applicator 1200 may further comprise moveable, slidable or a
collapsing or expanding bottom frame structure 1202, opposing fixed
configuration walls 1208, 1209 and opposing movable, pivotable or
hinged walls 1210, 1211. Frame structure comprises a pair of
slidable elements 1220, 1221 and pair of slidable elements 1222,
1223. Each of the pair of slidable elements 1220, 1221 and 1222,
1223 can slide together into a closed position (FIGS. 54A and 54C)
where there is a first distance d1 between walls 1208 and 1209. The
pairs of slidable element 1220, 1221 and 1222, 1223 can slide apart
into a second open or strained position where there is a second
distance d2 between the walls 1208, 1209 and where the distance d2
is greater than the distance d1 (as depicted in FIGS. 54B and 54A,
respectively).
Hinged wall 1210 comprises first and second wall portions or
segments 1212a, 1213a that are movably, pivotally or hingedly
connected to each other by connector 1214a, at a pivot point.
Hinged wall 1211 comprises a first and second wall segments 1212b,
1213b that are movably, pivotally or hingedly connected to each
other by connector 1214b at a pivot point. Wall segments 1212a and
1213b are movably, pivotally or hingedly coupled respectively to
opposite end sides 1208a, 1208b of wall 11081208. Wall segments
1212b and 1213a are movably, pivotally or hingedly coupled
respectively to opposite end sides 1209b, 1209a of wall 1209. The
walls 1208, 1209, 1210, 1211 are coupled to the frame structure
1202 to form a box-like structure with an opening (when in the
strained configuration) to provide access to a skin treatment
device 1240 attached across the bottom of the applicator to
attachment structures 1203, 1204, 1206, 1207, 1246, 1247. This
access allows a user to apply pressure to a skin treatment device
as or after it is applied to a skin surface, before removing the
applicator 1200 from the skin treatment device. Alternatively, a
pressure application device may be coupled to the applicator and
actuable to provide pressure through the opening to a skin
treatment device as or after it is being applied.
FIGS. 54A and 54C illustrate the applicator 1200 in a first,
unstrained position. The frame structure 1202 is in an unstrained
position where slidable elements 1220, 1221 and slidable elements
1222, 1223 are in a closed position. Wall segments 1212a and 1213a
are pivoted to form a v-shape collapsed into the box structure of
the applicator 1200, and opposing wall segments 1212b and 1213b are
pivoted to form a v-shape collapsed into the box so that the
distance between end walls is a distance d1. This position
facilitates loading of an unstrained skin treatment device onto the
applicator 1200.
After an unstrained device is loaded, the skin treatment device is
strained by applying opposing, outward forces to pulling rings
1218, 1219, respectively attached to wall segments 1213a, 1213b.
This force straightens side walls 1210, 1211 and pairs of sliding
elements 1220, 1221 and 1222, 1223 into an elongated or open
position as shown in FIGS. 54B and 54D, thus transferring a
separation force to the skin treatment device to strain the skin
treatment device widthwise (relative to its orientation and use on
along a length of an incision). In other variations, a single
collapsible wall attached generally about the midpoints of the
fixed configuration walls so only a single pulling force is used to
separate the fixed configuration walls.
When the device is in the strained position as shown in FIGS. 54B,
and 54D the wall segments 1212a, 1213a and 1212b, 1213b of walls
1210 and 1211 are pivoted. As shown in FIGS. 54B and 54D, the side
walls are over center or slightly hyper-extended or pivoted outward
to provide a strain in a width wise direction with the force
transferred to the skin treatment device through attachment
structures 1203, 1204. Thus the skin treatment device may be
strained in orthogonal directions or at least two directions, i.e.,
the applicator provides a bi-directionally or multi-directionally
strained skin treatment device. The applicator 1100 may be locked
or maintained in a strained configuration by way of over center
side walls. A latch or other stop such as a spring loaded pin may
engage one or more of inside surfaces of wall segments 1212a, 1213a
and 1212b, 1213b to maintain the applicator in its over center
locked position.
FIGS. 54E to 54I illustrate other variations of a tensioning
device, straining device or an applicator 1200 as previously
described with respect to FIGS. 54A to 54D, including an integrated
stamper 1230. The stamper 1230 is attached to the top of the
handle, actuator or tensioning device 1201 of FIG. 54A with
connectors 1235 that attach the device 1201 to the inside of the
stamper side wall 1234. The stamper comprises a handle 1231 coupled
to posts 1232 that extend through the top wall 1238 of the stamper
1230. Posts 1232 are coupled to pressure members 1239 inside the
stamper 1230. Prior to actuation, the pressure members 1239 are
positioned within walls 1234, 1242, 1243, 1244 of stamper 1230
above and the tensioning device 1201 as shown in FIG. 53G. Springs
1233 around the posts 1232 bias the handle 1231 in an upward (not
stamping) configuration. Visibility openings 1248, 1249
respectively in the handle 1231 and the top wall 1238 of the
stamper 1230 provide an opening through which the skin treatment
device and/or wound can be seen, for positioning of the applicator
1200 in an appropriate location.
As shown in FIGS. 54E, and 54G, when the tensioning device 1201 is
in an unstrained configuration, the length of its side walls 1210,
1211 are less than the length of the side walls 1242, 1244 of the
stamper 1230.
In FIGS. 54F and 54H, the tensioning device 1201 is in a strained
configuration where the side walls 1242, 1244 of the stamper 1230
are approximately that of the side walls 1210, 1211 of the
tensioning device 1201. In a strained configuration, an opening
1229 is provided in the tensioning device 1201 sized to receive the
pressure members 1239 therethrough. When a force is applied to the
handle 1231 and the tensioning device 1201 is in a strained
configuration, the pressure members 1239 extend down into and
through the opening 1229 in the applicator handle 1201, towards the
skin treatment device (not shown), to apply a force to areas of the
dressing where an adhesive interfaces the skin of the subject.
(FIG. 54I) Thus, where the adhesive is pressure activated, the
stamper 1230 applies a generally even pressure to the skin
treatment device. All stampers described herein may be constructed
of a foam or other compressible, conformable material which
translates the force applied to handle 1231 to the skin treatment
device (not shown). These other materials include silicones and
styrenic block copolymers (e.g. Kraton.RTM.), in a solid or porous
form.
As an option or alternative, the applicator 1200 may be provided
with attachment structures 1236, 1237 that comprise a hook or loop
structure of a hook and loop attachment mechanism, or any other
attachment structure described herein. Likewise, side attachment
structures 1203, 1204 may also be a hook or loop structure or any
other attachment structure.
FIGS. 55A to 55E illustrate a variation tensioning device,
straining device or applicator 1250 comprising a frame 1251 and a
pivoting handle 1262 that is used to strain a skin treatment device
loaded on to the applicator 1250. The handle 1262 is pivotally
attached at a first end 1263 to side walls 1256, 1257 near end wall
1255 of the frame 1251. An opposite second end 1264 of the handle
1262 extends above the frame 1251 when the applicator 1250 is in an
unstrained configuration as shown in FIGS. 55A, 55C and 55D. The
handle 1262 further comprises tensioning arms 1265 pivotally
coupled to sides 1266, 1267 of handle 1262 at first ends 1265a and
pivotally coupled to a sliding tensioning bar 1268 at a second
opposite ends 1265b. Each end 1269, 1270 of the sliding tensioning
bar 1268 is configured to slide in slots 1258 extending along a
portion of the length of side walls 1256, 1257 of frame 1251. When
the handle 1262 is squeezed so that its second end 1264 is moved
towards the frame 1251, a forced is transmitted from the handle
1262 through pivot point at first end 1265a to tensioning arms 1265
which translate the force to the sliding tensioning bar 1268 which
slides in the slots 1258 from the middle towards the end of the
frame 1251.
The sliding bar 1268 may further comprise a first attachment
structure 1286 to which one end of a skin treatment device may be
attached. A second attachment structure 1287 is positioned on the
bottom of the stationary end wall 1255 of the frame 1251. As shown
in FIGS. 55A, 55C, and 55D, when in an unstrained position, the
sliding tensioning bar 1268 is located at the inner end of the
slots 1258 where the attachment structure 1286 is a shorter
distance from the second attachment structure 1287 to facilitate
attaching or loading of an unstrained skin treatment device. As
shown in FIGS. 55B and 55E, in a strained configuration, the
sliding tensioning bar 1268 is located at the outer end of the
slots 1258 where the first attachment structure 1286 is a greater
distance from the second attachment device 1287. In use, the handle
1262 is moved from the open unstrained position to a second
strained position transferring the force to the tensioning arms
1265 which slide the sliding tensioning bar 1268 the length of the
slots 1258. When the handle 1262 is closed, it is latched or locked
into a strained position by locking or latching mechanism 1275. As
shown in FIG. 55C, the locking mechanism 1275 comprises a latch
1277 on the frame 1251 which engages a spring biased catch 1278 on
the end 1264 of the handle 1262. A release button 1279 on the end
1264 of the handle 1262 may be used to depress the spring loaded
catch 1278 to release it from the latch 1277.
After the skin treatment device is strained, the applicator 1250
may be used to press the skin treatment device to the skin. As
shown in FIGS. 55A to 55E, a stamper 1281 with one or more pressure
members 1283 may be used to apply a relatively even pressure to
portions of the skin treatment device 1285 where an adhesive
interfaces with the skin. The stamper 1281 includes a spring loaded
plunger handle 1282 that may be used to apply pressure to the skin
treatment device while or after the skin treatment device has been
applied to the skin. In other variations, the frame may provide an
opening on the superior surface of the applicator to provide access
to the superior surface of the skin treatment device, which allows
a user to apply manual pressure to the skin treatment device as or
after it is applied to the skin.
The applicator 1250 may also be configured to provide a mechanical
advantage by providing a substantially longer pivoting handle
relative to the coupling location of the tensioning arms from the
pivot point of the pivot handle. In some variations, the coupling
location as a percentage of the distance from the pivot point to
the distal end of the pivoting handle farthest away from the pivot
point may be less than about 50%, less than about 40%, less than
about 30%, or less than about 20%, for example.
FIGS. 56A to 56E illustrate another variation of a tensioning
device, straining device or an applicator 1300 with a stamper 1330.
The applicator 1300 comprises a tensioning device 1305 enclosed by
a housing 1331, a plunger 1332 on the top of the housing 1331, to
actuate the stamper 1330 which includes pressure members 1339
positioned or positionable within or through the tensioning device
1305. Slide actuators or side buttons 1301, 1302 extend from each
side 1333, 1334 of the housing. The side buttons 1301, 1302 may be
manipulated by squeezing them together to strain an attached skin
treatment device in a manner otherwise similar to that described
with respect to actuator 1100 of FIG. 53A.
The applicator 1300 includes a tensioning structure 1305 comprising
a moveable, slidable or a collapsing or expanding frame structure
1325. Frame structure 1325 comprises a pair of arms elements 1320,
1321 and pair of arms elements 1322, 1323. Arm elements 1320, 1321
and arm elements 1322, 1323 respectively are slidably coupled so
they can expand or collapse the frame structure 1325 by increasing
or decreasing the distance between sides or side walls 1308, 1309
of the frame structure 1325. The walls 1308, 1309 may also slide
together into a closed or unstrained position (FIGS. 56A, 56C, 56E)
or expand to an open or strained position (FIGS. 56B and 56D).
Attachment structures 1306, 1307 are coupled to and move with side
walls 1308, 1309. In an unstrained configuration (FIGS. 56A, 56C,
56E), the walls 1308, 1309 are a first shorter distance from each
other to facilitate loading of an unstrained skin treatment device.
In a strained configuration (FIGS. 56B, 56D) the opposing walls
1308, 1309 are a second greater distance from each other.
The tensioning structure 1305 may further comprise opposing
movable, pivotable or hinge members 1310, 1311. Hinged member 1310
comprises a first and second hinge segments 1312a, 1313a that are
movably, pivotally or hingedly connected to each other by way of
side button 1301, at pivot points 1314a and 1314b, respectively.
Hinged member 1311 comprises first and second hinge segments 1312b,
1313b that are movably, pivotally or hingedly connected to each
other by way of side button 1302 at pivot points 1315a, 1315b
respectively. Segments 1312a and 1313b may be movably, pivotally or
hingedly coupled respectively to opposite end sides 1308a, 1308b of
wall 1308. Segments 1312b and 1313a may be movably, pivotally or
hingedly coupled respectively to opposite end sides 1309b, 1309a of
wall 1309.
The tensioning structure 1305 further comprises guide structures
1343, 1344 coupled to walls 1308, 1309. (FIG. 56E). Guide rods
1341, 1342 are attached to side buttons 1301, 1302 and extend
inwardly through guide slots 1345, 1346 of guide structures 1343,
1344 to align movement of the hinge members 1310, 1311 with respect
to the frame structure 1325.
FIGS. 56A, 56C and 56E illustrate the applicator 1300 in a first,
unstrained position. The tensioning structure 1305 is in a
collapsed position. Segments 1312a, 1313a and side button 1301 are
pivoted to form a collapsed, folded or v-shape extending outward of
the applicator, and segments 1312b, 1313b and side button 1302 are
pivoted to form a convex or v-shape extending outward of the
applicator 1300 so that the distance between walls 1308, 1309 is
relatively shorter. This facilitates loading of an unstrained skin
treatment device. After an unstrained device is loaded, the skin
treatment device is strained by applying pressure to the side
buttons 1301, 1302. This forces segments 1312a, 1313a and segments
1312b, 1313b to pivotally move into a straightened, elongated or
open position as shown in FIGS. 56B and 56D and thus transferring a
separation force to the skin treatment device to strain the skin
treatment device.
The walls 1308, 1309, and arms 1320, 1321, 1322, 1323 form a
box-like structure with an opening 1329 (when in the strained
configuration) to provide access to a skin treatment device when
attached across the bottom of the applicator 1300 to attachment
structures 1306, 1307. The stamper 1330 may be actuated to apply
pressure to the skin treatment device by depressing the plunger
1332 to advance the pressure members 1339 through the opening 1329
and against a skin treatment device, as and/or after it is being
applied. The tensioning device 1305 stays fixed when the plunger
1332 is pressed. The pressure members are configured to compress
over the skin treatment device to distribute even force including
over non-planer surfaces or body areas. A mechanical, visual,
electrical, audible or other indicator may be included in the
stamper to signal when the correct amount of pressure has been
applied to the plunger, e.g. a MEMS pressure sensor or a mechanical
strain gauge coupled to the stamper mechanism. As shown, the
stamper 1330 may be guided with guide posts 1347, 1348 of guide
structures 1343, 1344 that are received by slots 1351, 1352 in
plunger 1332. Guide posts 1347, 1348 may include spring members
1349, 1350 that interact with lip 1353 in slots 1351, 1352 to bias
the stamper 1330 upward. This resists or prevents the pressure
members 1339 from deploying without applying a force and
facilitates reloading by springing stamper 1330 back in to a
loading position.
The applicator 1300 is shown in an open or unlocked position in
FIGS. 56A, 56C and 56E. When the device is in the strained position
as shown in FIGS. 56B and 56D, the hinge segments 1312a, 1313a and
1312b, 1313b of side structures 1310 and 1311 may be configured to
pivoted slightly inward and off-center to lock the device into
place or to resist or prevent collapse of the walls back into the
v-shaped or folded configuration. Springs 1361, 1362 attached to
posts 1363, 1364 on arm members 1320, 1321, and 1322, 1323
respectively bias the arm member 1320, 1321, and 1322, 1323
together. Thus, where the tensioning member 1305 is in the locked
position, the springs 1361, 1362 prevent the sliding members from
opening or unlocking. Thus the applicator 1300 may be maintained or
locked in a strained configuration. The springs 1361, 1362 also
spring the tensioning device back to a loading or unstrained
position when the device is unlocked for reloading. The springs
1361, 1362 help maintain the device in the unstrained configuration
to facilitate loading.
Alternatively, without the stamper 1330, the opening 1329 may
provide access to a user to apply pressure to a skin treatment
device as or after it is applied to a skin surface. In variations
without a stamper, the opening may be enlarged to facilitate
manipulation of the skin treatment device manually.
In a variation illustrated in FIGS. 56A to 56E the attachment
structures 1306, 1307 comprise hook or loop mechanisms. The
applicator or skin treatment device attachment structures may
comprise other types of attachment structures, including but not
limited to other attachment structures described or set forth
herein.
FIGS. 57A to 57I illustrate another variation of a tensioning
device, straining device, or applicator with a stamper. The
applicator 1400 comprises a tensioning device 1405 enclosed by a
housing 1431; a plunger 1432 on the top of the housing 1431 to
actuate the stamper 1430. The stamper 1430 includes pressure
members 1439 positioned or positionable within or through the
tensioning device 1405. Side buttons 1401, 1402 extend from each
side 1433, 1434 of the housing. The side buttons 1401, 1402 are
actuable by squeezing them together to strain a skin treatment
device attached to the applicator in a manner similar to that
described with respect to actuator 1100 of FIG. 53A and actuator
1300 of FIG. 56A.
The applicator 1400 includes a tensioning structure 1405 comprising
a fixed frame structure 1424 and moveable, slidable or a collapsing
or expanding frame structure 1425. Frame structure 1424 comprises
opposing side walls 1413, 1414 and end walls 1415, 1416, and middle
support structure 1417 extending from end wall 1415 to end wall
1416, which in combination form openings 1427, 1428 in frame
structure 1424. Openings 1427, 1428 may receive one or more
pressure members 1439 therethrough. End walls 1415, 1416 include
rails 1418 for slidably receiving rails 1404 of side walls 1408,
1409. Frame structure 1425 comprises side walls 1408, 1409 and
opposing movable, pivotable or hinge members 1410, 1411. Hinged
member 1410 comprises first and second hinge segments 1420, 1421.
Hinged member 1411 comprises first and second hinge segments 1422,
1423. Hinge segments 1420, 1421 and hinge segments 1422, 1423 are
movably, pivotally or hingedly connected to each other by way of
side buttons 1401, 1402 respectively at a pivot points so they can
expand or collapse the frame structure 1425, increasing or
decreasing the distance between sides or side walls 1408, 1409 of
the frame structure 1425. The walls 1408, 1409 may slide together
into a closed or unstrained position (FIGS. 57A, 57C, 57E and 57F)
or expand to an open or strained position (FIGS. 57B, 57D). Rails
1404 of walls 1408, 1409 engage rails 1418 to maintain the walls
1408, 1409 of frame structure 1425 in alignment with the frame
structure 1424 when sliding back and forth.
Attachment structures 1406, 1407 are coupled to and move with side
walls 1408, 1409. In an unstrained configuration (FIGS. 57A, 57C,
57E and 57F), the walls are a first shorter distance from each
other facilitating loading of an unstrained skin treatment device.
In a strained configuration (FIGS. 57B, 57D, 57G, 57H, 57I) the
opposing walls are a second greater distance from each other.
The moveable frame structure 1425 is further coupled to the
stationary structure 1424 with latching guide rods 1441 that are
attached to side buttons 1401, 1402. Latching guide rods 1441 slide
inward or outward through guide slots 1443 in middle support
structure 1417. Latching guide rods 1441 serve to align movement of
the hinge members 1410, 1411 with respect to the frame structure
1424 and frame structure 1425. Latching guide rods 1441 include
latch members 1442 at their distal ends. The latch members 1442
engage catches 1444 at the ends of guide slots 1443 when the
buttons 1401, 1402 are pushed in and the device is in a strained
position.
FIGS. 57A, 57C, 57E and 57F illustrate the applicator 1400 in a
first, unstrained position. The tensioning structure 1405 is in a
collapsed position. Hinge segments 1420, 1421 and side button 1401
are pivoted to form a convex or v-shape extending outward of the
applicator, and hinge segments 1422, 1423 and side button 1402 are
pivoted to form a collapsed, folded or v-shape extending outward of
the applicator 1400 so that the distance between end walls 1408,
1409 is relatively shorter. This facilitates loading of an
unstrained skin treatment device. After an unstrained skin
treatment device is loaded, it is strained by applying pressure to
the side buttons 1401, 1402. This forces hinge segments 1420, 1421
and hinge segments 1422, 1423 to pivotally move into a
straightened, elongated or open position as shown in FIGS. 57B and
57D and thus transferring a separation force to the skin treatment
device to strain the skin treatment device.
The walls 1408, 1409, and hinge members 1410, 1411 form a box-like
structure with an opening 1429 through moveable frame structure
1425 (when in the strained configuration) to provide access to a
skin treatment device attached across the bottom of the applicator
1400 to attachment structures 1406, 1407. The stamper 1430 may be
actuated to apply pressure by depressing the plunger 1432 to
advance the pressure members 1439 through the opening 1429 and
openings 1427, 1428 to a skin treatment device as or after it is
being applied. As shown, the stamper 1430 may be guided with guide
posts 1447 fixed to middle support structure 1417. Guide posts 1447
are received by slots 1451 in plunger 1432. Guide posts 1447 may
include spring members 1449 that interact with lip 1453 in slots
1451 to bias the stamper 1430 upward. This resists or prevents the
pressure members 1339 from deploying without applying a force and
facilitates reloading by springing stamper 1430 back in to a
loading or unstrained position.
The device is shown in an open or unlocked position in FIGS. 57A,
57C, 57E and 57F. When the device is in the strained position as
shown in FIGS. 57B, 57D, 57G, 57H and 57I, buttons 1401, 1402 are
pressed inward and latching members 1442 on the guide rods 1441
engage with catches 1444 in the T-bar 1470 (contiguous with the
guide slots 1443) to lock the buttons 1401, 1402 into place in a
strained position. Springs 1449 bias guides rods 1441 outward so
that when the latch members 1442 are released from the catches
1444, the buttons 1401, 1402 spring open. The latching members 1442
remain latched until a sufficient stamping force is applied as
described below.
A T-bar release 1470 may be slidably positioned in the middle of
middle support structure 1417. The T-bar 1470 may be biased upward
by spring members 1461 that are positioned over alignment pins 1462
for aligning T-bar 1470 over guide slots 1443. In an upward biased
position, the T-bar has openings with catches 1444 that are
contiguous with guide slots 1443. The tensioning member 1405
remains in the locked position, until the stamper 1430 is
depressed, and a ceiling 1480 of the stamper engages the top of the
t-bar 1470 to depress the T-bar 1470 typically biased upward by
spring members 1461. The catches 1444 move downward to release the
latching member 1442 and the guide rods 1441 from locking
engagement with the catches 1444. When released, springs 1449 bias
guide rods 1441 outward to thereby spring buttons 1401 1402 back
into a loading or unstrained configuration.
Alternatively, without the stamper 1430, the opening 1429 may
provide access to a user to apply pressure to a skin treatment
device as or after it is applied to a skin surface.
In a variation illustrated in FIGS. 57A to 57I, the attachment
structures 1406, 1407 comprise a hook or loop mechanism. The
applicator or skin treatment device attachment structures may also
comprise other types of attachment structures, including but not
limited to other attachment structures described or set forth
herein.
Referring to FIGS. 58A to 58I, other variations of a tensioning
device, straining device or applicator 1500 may include an
integrated stamper 1530 and release mechanism. The applicator 1500
comprises a first pivoting frame portion 1501a having a first
handle member 1502 with lower frame portion 1504 and a second
pivoting frame portion 1501b with a second handle member 1503 with
lower frame portion 1505. Attachment structures 1506, 1507 are
respectively coupled to bottom of lower frame portions 1504, 1505.
Attachment structures 1506, 1507 each comprise a pivoting, or
rotating structure, e.g. roller 1508 having an attachment mechanism
such as e.g., hooks or loops 1509 attached to a plurality of
locations on the roller 1508. The hooks or loops 1509 may be used
to attached to a skin or wound treatment device such as, for
example, as described with respect to the skin treatment device 700
and attachment devices 716, 718, 732, 734 illustrated in FIGS. 47
and 48 herein. Alternative attachment structures may be used as
discussed in further detail herein.
The pivoting frame portions 1501a, 1501b are pivotally coupled by
connector 1510 to provide a pivot point 1512 to transfer force from
the applicator 1500 to a skin treatment device coupled to the
attachment structures 1506, 1507, to thereby strain the skin
treatment device prior to placement on skin.
FIGS. 58A and 58B illustrate an actuator or handle configuration
prior to straining a skin treatment device for application to the
skin of a subject. A skin treatment device may be attached to the
attachment structures 1506, 1507. When an external force is applied
to the actuator, e.g., the handle members 1502, 1503 of the
applicator 1500 are squeezed together, the force is transferred to
provide a separation force between the attachment structures 1506,
1507, coupled respectively to the bottom of the lower frame
portions 1504, 1505. Optionally, the handle may be provided with a
distance from the top 1511 to the pivot point 1512 that is greater
than the distance from the pivot point 1512 to an attachment
structure 1506 or 1507. Thus, the actuator or handle may provide a
mechanical advantage greater than 1 when actuated.
FIG. 58C schematically illustrates an actuator or handle
configuration of the applicator 1500 where an attached skin
treatment device 1557 is in a strained configuration prior to
applying the stamper. The handle members 1502, 1503 have been
squeezed together and a separation force has been exerted between
the attachment structures 1506, 1507 to strain the attached skin
treatment device.
The applicator 1500 includes a mechanism to maintain the skin
treatment device in a strained configuration. Any of a variety of
skin treatment devices may be used with this applicator 1500,
including but not limited to skin treatment devices illustrated in
FIGS. 43A to 43C and others described herein. In accordance with a
variation, the handle members 1502, 1503 are releasably lockable
together by a locking or latching mechanism 1515 that prevents
separation of the handle members 1502, 1503 and thus the release of
the strain exerted on the skin treatment device. As shown in FIG.
58B, the locking mechanism 1515 is depicted prior to closure of the
handle members 1502, 1503. Alignment pin 1521 of handle 1503 fits
into alignment opening 1520 of handle 1502. The locking mechanism
1515 comprises a spring loaded latch 1516 that has a hook 1520 that
latches on to catch 1517 as the handle members 1502, 1503 close.
The latch 1516 may be released by depressing release member 1518 to
compress spring 1519 and separating handle members 1502, 1503. By
locking the applicator in a strained position, a predetermined
strain of a given skin treatment device may be achieved. Other
locking mechanisms, including but not limited to other locking
mechanisms described herein may be used. A variable locking
mechanism may be used to vary the amount of strain for a given skin
treatment device.
Pivoting frame portions 1501a, 1501b each further comprise guide
slots 1532 coupled to the lower frame portions 1504, 1505. When the
handle members 1502, 1503 are coupled together, they form a plunger
for actuating the stamper 1530. The stamper 1530 comprises handle
members 1502, 1503 which are attached to pressure members 1536 on
their distal ends. Slots 1532 are coupled to the lower frame
members 1504, 1505 and pegs 1534 on the handle members 1502, 1503
are slidable within the slots 1532.
When the device has been strained and the handle members have been
latched (FIG. 58C) the dressing may be applied to the skin of a
subject. The handle members 1502, 1503 that are coupled together
may be depressed to apply a pressure to the back of the dressing
with pressure members. Prior to stamping the dressing, detents 1533
within the guide slots 1532 prevent the stamper from self-deploying
by engaging with pegs 1534. When the handle members 1502, 1503 are
depressed, the force overcomes the detents 1533 and the pegs 1534
slide distally through the slots 1532. The stamper 1530 applies
pressure with pressure members 1536 to the skin treatment device
1557 to activate the adhesive.
The applicator 1500 may further includes releasable attachment
structures 1506, 1507. According to a variation shown in FIGS. 58A
to 58I, the attachment structures 1506, 1507 each comprise lockable
releasable rollers 1508. The rollers 1508 are locked when loading
and applying a skin treatment device. They may be released to
provide for easy release of the attachment structures.
The release and locking structure 1550 comprises a release button
1551, pivoting lifter arms 1552, and fork members 1554 biased into
a locking position (e.g. downward) with springs 1557. The pivoting
lifter arms 1552 are movably coupled to a first end of the fork
members 1554. Fork members 1554 include roller engaging forks on
the opposite end. The locking structure 1550 further comprises tabs
1556 on the rollers 1508 that engage the fork members 1554 to lock
the rollers 1508. The release button 1551 has a lever end 1555
which may be pivotably moved with the release button 1551 to
actuate the pivoting lifter arms 1552, which that in turn lift the
attachment forks members 1554 from engagement with one of the tabs
1556 on each of the rollers 1508.
To remove the applicator 1500 from the skin treatment device, after
the stamper 1530 has been used to apply sufficient pressure to the
skin treatment device, the release button 1551 may be lifted to
release the fork members 1554 from tabs on the roller 1508. (FIGS.
58G to 58I) The internal strain on the skin treatment device places
a tangential force on the rollers 1508 causing them to rotate
towards the skin treatment device. This rotation replicates a peel
motion that releases the Hook and loop connection.
Each roller 1508 has four tabs 1556 and four corresponding hook or
loop mechanisms 1509. After the roller 1508 is released it rotates
and the fork member 1554 engages an adjacent tab 1556 and an
adjacent hook or loop mechanism 1509 is positioned on the bottom of
the roller 1508 for reloading the next skin treatment device.
FIGS. 59A to 59C illustrate another variation of an applicator
1600. Applicator 1600 comprises a pair of spring or resilient
members 1605. Each resilient member 1605 extends from attachment
foot 1601 on a first end 1602 to attachment foot 1603 on an
opposite end 1604. Each resilient member 1605 is positioned on
sides 1608, 1609 of applicator 1600. A stamper 1610 is positioned
between resilient members 1605. Stamper 1610 includes handle 1611
comprising an arching member extending from first end 1602 to
second end 1604 and attached to planar support 1614. The handle
1611 is coupled to plunger 1612 attached to planar support 1614. A
pressure member 1613 is attached to the bottom of the planar
support 1614. When the stamper 1610 is actuated, the pressure
member 1613 applies pressure to a strained skin treatment device
attached to the attachment structures, 1606, 1607. Plunger 1612 has
laterally extending rods 1615 that prevent separation of the
stamper 1610 from the resilient members 1605. As shown in FIG. 59A,
the resilient members 1605 are compressed to load an unstrained
skin treatment device on to attachment structures 1606, 1607 which
may comprise one or more variation of attachment structures. The
skin treatment device may be loaded on to a carrier that holds the
resilient members until they are released to strain the skin
treatment device. The resilient members may also be manually
compressed and released to strain the skin treatment device. FIG.
59B shows the applicator 1600 in a strained configuration prior to
stamping. FIG. 59C shows the applicator 1600 in a strained and
stamped configuration.
FIGS. 60A to 60D illustrate variations of tensioning device,
straining device, or applicator 1650 in which the applicator 1650
is self-releasing from an applied skin treatment device. The
applicator 1650 comprises a handle 1651 and a resilient member 1654
coupled to the handle 1651, attachment feet 1652 with upwardly
curved ends 1653 and coupling edges 1658, 1659, and attachment
structures 1656, 1657 on the bottom of the attachment feet 1652. A
skin treatment device 1660 for use with the applicator is
illustrated loaded on a carrier device 1670. The skin treatment
device has an adhesive side 1661; an attachment side 1662; end
portions 1664, 1665 with attachment features 1666, 1667 for
attaching to attachment structures 1656, 1657 of the applicator
1650. The adhesive side 1661 is positioned on the carrier device
1670. Carrier device 1670 comprises a rigid planar backing 1671
with coupling structures 1678, 1679 on each end. A releasable
locking tab 1673 is located on coupling structure 1678 to help peel
or remove the carrier 1670 from the skin treatment device 1660.
In use, the resilient member 1654 may be squeezed by hand to reduce
the distance between the attachment feet 1652 and to load a carrier
1670 and unstrained skin treatment device 1660 on to the applicator
1650. The coupling edges 1658, 1659 of the applicator engage with
the coupling structures 1678, 1679 of the carrier device 1670. The
carrier device 1670 maintains the skin treatment device 1660 in an
unstrained configuration until it is removed from the skin
treatment device 1660. The locking tab 1673 is rotated upward to
lock the skin treatment device in an unstrained position. (FIG.
60A) To strain the skin treatment device, the resilient member 1654
is released and then when the locking tab 1673 is released by
rotating it downward and the carrier 1670 is removed from the skin
treatment device. The resilient member 1652 applies a separation
force to strain the skin treatment device 1660 which may then be
applied to the skin of a subject. (FIG. 60B). The device may then
be released by rotating the applicator 1650 forward on to the
curved ends 1653. (FIG. 60C) The removal feature may be used with
various attachment structures including hook and loop combined
attachment structures. The applicator 1650 may also include a
stamper 1680 where the handle 1651 acts as a plunger handle and is
used to depress stamper 1680 to apply pressure with pressure
members 1681 (FIG. 60D).
FIGS. 61A to 61F illustrate still another variation of a tensioning
device, straining device or applicator 1700 in which the applicator
1700 is self-releasing from an applied skin treatment device. The
applicator 1700 comprises a handle 1701 and a resilient member 1704
coupled to the handle 1701, pivoting attachment feet 1702 coupled
to the ends 1705 of the resilient member 1704. As shown in FIG.
61D, the resilient member 1704 comprises a latch 1716 pivotally
coupled to the each end portion 1705 of the resilient member 1704.
The latch 1716 includes a latching finger 1718 extending laterally
outward of the resilient member 1704 and a release bar 1719
extending laterally inward of the resilient member 1704. The
resilient member also includes a resilient tab 1715 extending
laterally outward from each end portion 1705. The pivoting
attachment feet 1702 each comprise a hinge 1708 attached with a pin
1709 to an end portion 1705 of the resilient member 1704. The
pivoting feet 1702 each further comprise a planar bottom portion
1703 with attachment structures 1706, 1707 thereon. The pivoting
feet 1702 each further comprise a locking structure 1710 on the top
of the feet 1702 having a top edge 1711 for engaging a latching
finger 1718 of a latch 1716, and a window 1712 for receiving a tab
1715 extending laterally outward from each end portion 1705 of the
resilient member 1704.
A stamper 1730, comprising a plunger handle 1731 which may be
coupled to a T-bar 1732 which in turn is coupled to a backing 1733
with pressure members 1735. The backing 1733 may be configured to
extend laterally around the pressure members 1735, at least around
ends 1734 of backing 1733. The stamper 1730 may be used to apply
pressure to an applied skin treatment device with pressure members
1735.
In use, the resilient member 1704 is squeezed by hand to reduce the
distance between the pivoting feet 1702 and to load an unstrained
skin treatment device 1720 on to the applicator 1700. The skin
treatment device 1720 has an adhesive side 1721; an attachment side
1722; end portions 1724, 1725 with attachment features 1726, 1727
for attaching to attachment structures 1706, 1707 of the applicator
1710. To strain the skin treatment device 1720, the resilient
member 1704 is released. The resilient member 1704 applies a
separation force to strain the skin treatment device 1720 which may
then be applied to the skin of a subject.
FIG. 61A shows a skin treatment device 1720 loaded onto and
strained by the applicator 1700 before the skin treatment device
1720 has been stamped. The latch fingers 1718 of the latches 1716
are hooked over the top edges 1711 of locking structures 1710 while
receiving tabs 1715 extend laterally outward from each end portion
1705 of the resilient member 1704 and through windows 1712. (FIGS.
61A and 61D) The latch fingers 1718 hold the pivoting feet 1702 in
a flat position and prevent downward rotation of the pivoting feet
1702. The tabs 1715 act as alignment pins and resist or prevent
upward rotation of pivoting feet 1702.
FIGS. 61B and 61F depict the stamper 1730 depressed. The stamper
1730 releases the pivoting feet 1702 and attachment structures
1706, 1707 from engagement with the attachment features 1726, 1727
of the skin treatment device 1720. When the stamper 1730 is
depressed, the pressure members 1735 apply pressure to the back of
the skin treatment device and the ends 1734 of backing 1733 engage
the release bars 1719 moving them down and lifting the latching
finger 1718 which permits the pivoting feet 1702 to rotate down as
the plunger handle 1731 is pulled up to remove the applicator 1700
from the skin treatment device 1720. As the pivoting feet 1702 are
released, both feet 1702 pivot inward due to the internal strain in
the skin treatment device. This rotational motion breaks the
contact between the hook and loop of attachment structures 1706,
1707 and attachment features 1726, 1727, at a lower force allowing
the applicator 1700 to detach without substantially pulling the
skin treatment device 1720 off of the skin or reducing the amount
the skin treatment device may be pulled off of the skin. The
removal feature may be used with various attachment structures
including hook and loop combined attachment structures.
FIGS. 62A to 62D illustrate an example of a self-expanding
tensioning device, straining device or applicator 1750. The
applicator 1750 comprises opposing end supports or bars 1752 have a
fixed shape and opposing sliding side bars 1754. Bars 1752, 1754,
form an open frame structure 1751 with opening 1769. Each of side
bars 1754 comprises an inner tube 1755 with an end 1756 that slides
within an outer tube 1757. A spring 1758 is positioned in each
outer tube 1757 and interfaces with end of inner tube 1755 to bias
inner tube 1755 and outer tube 1757 apart. Stationary end bars 1752
have attachment structures 1753 along the bottom.
A loader or dispenser 1760 comprises a planar bottom 1761 and side
walls 1762 forming an open box. The box is sized to receive an
unstrained skin treatment device 1770 having attachment features
1772 for engaging with attachment structures 1753 of the applicator
1750. As shown in FIG. 62A, an unstrained skin treatment device
1770 is placed within the loader 1760 with the attachment features
1772 facing up. The side bars 1754 of the applicator 1750 are
compressed together and the applicator 1750 is placed within loader
1760 with the end bars 1752 and sliding side bars 1754 engaging the
inside of side walls 1762 to prevent the side bars 1754 from
sliding open. Attachment structures 1753 of applicator 1750 are
facing down and aligned with the attachment features 1772 of the
skin treatment device 1770 so that they are coupled together. As
shown in FIG. 62B, the applicator 1750 and skin treatment device
1770 are removed from the loader 1760 and as shown in FIG. 62C, the
applicator 1750 self-expands with biasing force of springs 1758 and
strains the attached skin treatment device 1770 by applying a
separating force. The skin treatment device 1770 is then applied to
the skin of a subject using applicator 1750, and as shown in FIG.
62D, the applicator 1750 is separated from the skin treatment
device 1770.
FIGS. 63A and 63B illustrate a variation of an attachment system
2000 to attach a skin treatment device to an applicator or
tensioning device and to strain the skin treatment device that
includes an attachment structure for an applicator or tensioning
device and an attachment feature for a skin treatment device. The
attachment system includes pockets 2005 that are formed on and
extend the length of the sides 2011 of a skin treatment device
2010. The pockets 2005 may be formed by folding over edges of the
skin treatment device and bonding the folds on the outer edges and
at various points along the length to form a plurality of pocket
portions 2005a. An attachment structure 2003 that may be used on an
applicator or tensioning device in accordance with one or more
variations of an applicator or tensioning device is shown
comprising a side 2015 with a plurality of tabs 2012 or a plurality
of cutouts 2014. In use, an applicator or tensioning device has a
plurality of attachment structures 2003 which are placed in a
plurality of pockets 2005 of a skin treatment device 2010. The tabs
2012 fit into pocket portions 2005a. A separation force is applied
with attachment structures 2003 to the skin treatment device to
strain it in one or more directions. In accordance with variations
of the invention, multiple tabs or fingers may be provided on the
attachment structures to adapt or conform to uneven or undulating
skin.
FIGS. 64A to 64E illustrate variations of an attachment system to
attach a skin treatment device to an applicator or tensioning
device and to strain the skin treatment device that includes an
attachment structure for an applicator or tensioning device and an
attachment feature for a skin treatment device. A skin treatment
device 2030 is pre-mounted to plastic feet 2025 which may be
attached to the skin treatment device 2030 in one of several
manners. For example, the plastic feet 2025 may be inserted into a
pocket, or attached by a hook or loop mechanism or other attachment
structure. The plastic feet 2025 have notched attachment pegs 2026
that are easily accessible to a tensioning device or applicator.
Any one or more of the applicators described herein may be used,
for example. FIG. 64B shows an applicator 2022 with attachment
structures 2023 comprising mating features 2024 for snapping pegs
2026 on to applicator 2022. The applicator then applies a
separation force to the plastic feet to strain the skin treatment
device 2030. The applicator may apply the separation force a
variety of ways including but not limited to those described in the
various embodiments herein. FIG. 64B shows pivot arms that may be
pivoted e.g. using a handle to exert a separation force.
FIG. 64C illustrates variations of system that includes an
attachment structure for an applicator or tensioning device and an
attachment feature for a skin treatment device. Attachment
structure 2024a comprises a spring biased hook 2024a that may hook
on to a wire loop 2026a on a plastic foot 2025a.
FIG. 64D illustrates an alternative attachment system that includes
an attachment structure for an applicator or tensioning device and
an attachment feature for a skin treatment device. Attachment
structure 2030 comprises an angled attachment feature 2036 that
engages an angled attachment feature 2035 of a skin treatment
device.
FIG. 64E illustrates an alternative attachment system that includes
an attachment structure for an applicator or tensioning device and
an attachment feature for a skin treatment device. Attachment
structure 2040 comprises an angled attachment feature 2046 that
engages an angled attachment feature 2045 of a skin treatment
device. Angled attachment feature 2046 is coupled to a spring
mechanism 2041 that biases the attachment feature 2046 and
attachment feature 2045 downward. This may assist in applying a
skin treatment device to an uneven area of skin or body
profile.
FIGS. 64F to 64I illustrate an alternative attachment system that
includes an attachment structure for an applicator. The applicator
2060 includes attachment structures 2066 coupled by way of torsion
springs or spring loaded pivots 2063 to the applicator 2060. Each
attachment structure 2066 comprises a convex foot 2068 with hooks
(of a hook and loop attachment mechanism). In FIGS. 64F and 64H, a
skin treatment device 2070 is loaded onto attachment structures
2066 and the spring loaded pivot 2063 is locked in position using a
locking mechanism for example as described herein. The convex foot
2068 may serve to apply a generally more uniform pressure on the
skin treatment device 2070 when applied to uneven skin. As shown in
FIGS. 64H and 64I, the attachment feature 2071 on the skin
treatment device 2070 comprises a loop (of a hook and loop
mechanism). When the spring loaded pivots 2063 are released, the
convex feet 2068 rotate so that fewer rows of hooks are peeled from
the loop at a time to reduce the required force at the time of
removal, release or detachment of the hooks form the loops or of
the attachment structures 2066 of the applicator 2060 from the
attachment features 2071 of the skin treatment device 2070.
FIGS. 64J and 64K illustrate variations of an attachment system for
a tensioning device, straining device or applicator. Attachment
structure 2075 comprises a roller 2076 that may be locked and
unlocked in a manner similar to roller 1508 as described with
respect to FIGS. 58A to 58I. The roller 2076 comprises a plurality
of attachment fingers 2077 for engaging openings or pockets in a
skin treatment device. As shown in FIG. 64J, fingers 2077 may be
positioned in openings 2079 of skin treatment device 2078. In the
loaded and locked position, the roller 2076 is positioned with the
fingers 2077 facing away in a horizontal plane from the middle of
the skin treatment device 2078. After the skin treatment device
2078 is applied, the rollers 2076 are released, unlatched or
unlocked. The internal tension of the strained skin treatment
device pulls or rotates, the fingers 2077 and roller 2076 in a
manner that translates the fingers so they are closer to
perpendicular to the skin and the attachment structure 2075 can be
removed from the skin treatment device.
FIGS. 64L and 64M illustrate variations of an attachment system for
a tensioning device, straining device or applicator. As shown in
FIG. 64L, a linked locking bar 2081 is coupled to a translating
foot 2082 with hook or loop material 2083, in a locked position
facing an attachment feature 2086 of a skin treatment device 2085.
As shown in FIG. 64M, the linked locking bar 2081 is pulled up and
out of the locking position, for example using lifter arms 1552 as
described with respect to FIGS. 58A to 58I. The translating foot
2082 which is moved by the locking bar 2081 to a position more
perpendicular with respect to attachment feature 2086 of a skin
treatment device 2085.
FIGS. 65A to 65C illustrate variations of system that includes an
attachment structure for an applicator or tensioning device and an
attachment feature for a skin treatment device. An attachment
structure system 2100 is illustrated having an attachment structure
2106 comprising attachment tabs 2107 at the end of a sliding planar
member 2108 that slides within slot 2103 of housing wall 2102.
Button 2104 is attached to the outside of the housing wall 2102
extends into housing wall 2102 and is attached to the sliding
planar member 2108. The button is slidable up and down in the
housing wall to extend or retract the tabs 2107 at the end of the
sliding planar member. In use, the tabs 2107 extend out of the
housing wall and are used to engage an attachment structure such
as, e.g. a pocket, of a skin treatment device (not shown) in a
manner similar to that described with respect to attachment
structure 2003 and skin treatment device 2010 of FIG. 63A. A second
attachment structure system (not shown) attaches to an attachment
structure on another side of the skin treatment device. A
separation force is applied through the attachment systems to
strain the skin treatment device. After the strained skin treatment
device is applied to the skin, the buttons 2104 on each housing
wall of each attachment system 2100 may be used to retract the
attachment structures to provide for release, removal or detachment
of the applicator or straining device from the skin treatment
structure.
FIGS. 66A to 66B illustrate a skin frame 2200 configured to
pre-strain skin prior to application of a skin treatment device to
the skin that will hold the skin in a strained configuration. The
frame 2200 comprises an inner sliding frame 2201 and an outer
sliding frame 2202. Attachment structure 2206 is attached to the
bottom of inner sliding frame 2201 on a first side 2203 of the skin
frame 2200. Attachment structure 2207 is attached to the bottom of
the outer sliding frame 2202 on a second side 2204 of the skin
frame 2200. The attachment structures 2206, 2207 are configured to
attach to skin, for example by way of adhesive, friction pads,
microneedles and the like. The friction pads may comprise a
silicone, a viscoelastic polymer such as styrenic block polymers,
and the like. In use, the attachment structures 2206, 2207 are
attached to skin when the skin frame is in the first position as
shown in FIG. 66A. In the first position the distance between the
attachment structures is L1. As shown in FIG. 66B, the sides 2203,
2204 of the skin frame are slid together by sliding inner frame
2201 and outer frame 2202 with respect to each other. Thus the
distance between the attachment structures is L2 where L2 is less
than L1, thus straining the skin to which the attachment structures
2206, 2207 are attached. A skin treatment device may then be placed
through opening 2205 of the skin frame. The skin treatment device
is configured to hold the skin in place. The skin treatment
structure may be an unstrained or a strained treatment structure.
For example such as the dressings, wound treatment device or skin
treatment devices described herein or use with an applicator.
While the particular examples illustrated and described herein
include specific combinations of the variety of features described
herein, one of skill in the art will understand that other
combinations of features described herein are contemplated. For
example, Applicators 100, 200, 220, 240, 260, 280, 300, 320, 714,
730, 70, 900, 1000, 1100, 1200, 1250, 1300, 1400, 1500, 1600, 1650,
1700 and 1750 are each depicted with a particular attachment
mechanism but may also be designed with other attachment mechanisms
(e.g. those shown in skin treatment devices 2, 600, 630, 650, 660,
670, 680, 700, or attachment mechanisms depicted in FIGS. 64C to
64M). Likewise, applicators comprising a stamper may also be
configured without a stamper and provided with an access opening to
permit direct pressing of a skin treatment device by the user.
In another variation, the device may be applied without an
applicator by grasping the flap regions and manually stretching the
device. The stretched device may then be applied to the skin and
allowed to recover. In still another variation, instead of
pre-stretching the device, the underlying skin may be
pre-compressed while an unstrained device is adhered or attached to
the compressed skin. Once attached, the compressive force acting on
the skin may be removed to permit transfer and equilibration of the
skin compression to tensile strain acting on the device.
To facilitate removal of the device, an outer edge of the device
may be lifted and slowly peeled off, working toward the midline or
incision site. In some examples, water, isopropyl alcohol or other
adhesive removal agent may be administered to the device/skin
interface to facilitate removal. The same agent may also be used to
remove any remaining adhesive found on the skin after complete
removal of the device. If another device is to be applied to the
same site, the skin may be dried before the replacement device is
applied.
While this invention has been particularly shown and described with
references to embodiments thereof, it will be understood by those
skilled in the art that various changes in form and details may be
made therein without departing from the scope of the invention. For
all of the embodiments described above, the steps of the methods
need not be performed sequentially.
* * * * *
References